Contracts Support Associate - Temporary Position Baudette, MN Laboratory Equipment Specialist Baudette, MN Manager, Analytical Development Baudette, MN Operator I - Manufacturing and Packaging (1st and 2nd Shift) Baudette, MN QA Specialist I Baudette, MN QC Analyst Baudette, MN QC Chemist/Sr. QC Chemist Baudette, MN QC Technician Baudette, MN Scientist I Baudette, MN Senior Scientist I Baudette, MN Supervisor, Quality Control Baudette, MN Technician - Product Development Baudette, MN Contracts Support Associate - Temporary Position The temporary Contracts Support Associate position is responsible for daily data entry as it relates to contract support related activities. This includes order processing, shipping paperwork, invoicing, advanced ship notices and other duties as assigned. This temporary position is expected to be for 3 to 6 months in duration. Position Responsibilities: 1. Order Entry - Receipt-entry (EDI, Fax, e-mail). 2. Shipping-Invoicing - Prepare all docs pre and post shipment, maintain files, send invoices and advanced ship 3. CSII Orders - Process, verify, track orders, and maintain electronic 222 log. 4. Performs other duties as assigned or requested. Position Requirements: This position requires an Associates degree and 1-2 years related experience or training, or equivalent combination of education and experience. This position also requires: - Ability to manage multiple projects and competing priorities. - Ability to work well under pressure and to work within short deadlines. - Excellent computer skills in Microsoft Windows Environment. Must include Excel with demonstrated aptitude for Access and/or database management. - Excellent organizational and multitasking skills, strong work ethic, and emphasis on attention to details. - Work independently while effectively communicating and coordinating work efforts with others. Apply Now! | Top Laboratory Equipment Specialist This position is responsible for assisting with administration of the Chromatography Data System (CDS) and other 21 CFR Part 11 compliant systems. Additional responsibilities include assisting with the purchase and qualification of new analytical equipment and software, troubleshooting and repairing equipment issues, and maintenance of equipment in the QC Laboratory. Position Responsibilities: Provide user support for the Quality Control Laboratory regarding the CDS including adding new instruments, developing of methods and reports and assisting with daily system maintenance. Qualification of new and existing analytical equipment and instrumentation including any computer and the software/firmware required to control such equipment or instrumentation. Troubleshoot/repair instrumentation including coordinating with external vendors and maintaining equipment per governing procedures. Provide training on how to use the CDS and other instrumentation. Create, update and maintain validated Excel workbooks used within the laboratory. Performs other duties as assigned or requested. Position Requirements: Minimum Education - Bachelor's Degree in Chemistry, Engineering or another related field Minimum Experience - 1 year in a Pharmaceutical Quality Control analytical laboratory. - 2 - 5 years in an analytical chemistry lab in a Pharmaceutical or similarly regulated environment Minimum Field of Expertise - Ability to coordinate and manage multiple projects in a fast-paced environment. - Ability to solve complex issues and assignments independently with minimum supervision. - Ability to train and influence others to use new technology in the laboratory. - Attention to detail - Excellent Organizational and follow through skills - Excellent technical writing skills. - Excellent written and verbal communication skills. - Must be able to work well within a team environment Preferred Experience - Knowledge of GMP's and 21 CFR Part 11 - Knowledge of USP <1058> Analytical Instrument Qualification - Knowledge of Windows based networking and operating systems Apply Now! | Top Manager, Analytical Development This position is responsible for managing and directing activities and personnel related to Analytical Development in support of Operations. Position Responsibilities: Responsibilities include managing and/or coordinating analytical method development, validation and transfer, cleaning validation test methods. This includes providing input into time and materials for new projects with business development, and managing these activities to ensure efficient operation. Coaches and trains analysts and provides instrumental and analytical expertise to enable analysts to perform quality work in a time efficient manner. To ensure a safe work environment for self and others through training, proper handling of chemicals and maintaining good housekeeping conditions. Provide instrumental and analytical expertise. Assists in the development and revision of methods, specifications, and other documentation related to the analytical and validation functions to comply with Company and FDA guidelines. This includes writing and updating test methods and specifications for raw materials, intermediates, and finished product, standard operating procedures and change requests as required. Writing and revising analytical method validation/transfer and cleaning validation protocols and reports. Conduct laboratory and laboratory equipment investigations in the area to thoroughly document atypical and out of specification results through approved investigation and non-conformance reports. Ensure methods and SOPs are up to date, concise and reflect GMPs and GLPs. Support facility technical operations in GMP related issues and continue to pursue expertise and personal development. This includes providing analytical support and expertise in support of the Baudette Facility Operations. Continue to develop expertise in GLP and new technologies pertaining to Quality Control, Microbiology and Analytical Development in support of Baudette Facility Operations. Position Requirements: Bachelors Degree in Chemistry/Biochemistry. Education, training, or certification in Management and Leadership is preferred. Minimum of 10 years experience in a Pharmaceutical Quality Control and/or Analytical Development Environment. Must have Demonstrated expertise of cGMPs and GLPs. Sound knowledge of method development/validation and method transfer requirements. Knowledge of stability guidelines and regulations. Competency in team building, problem solving, planning and initiative. In-depth knowledge of laboratory instrumentation. Ability to follow, prepare and explain technical matters and procedures. Ability to make decisions independently after appropriate input from areas that will be affected. Ability to manage multiple projects and competing priorities. Ability to perform under stressful situations. Excellent leadership, communication, and interpersonal skills. Apply Now! | Top Operator I - Manufacturing and Packaging (1st and 2nd Shift) This position is responsible for operating pharmaceutical packaging machines/equipment. Position Responsibilities: Assists in material handling, equipment set-up and breakdowns, documents process according to Master Production Records, and works with trained operators at assigned work centers to learn all aspects of the position, including batch record documentation, equipment set-up, operation and clean up. Position Requirements: This position requires a High School Diploma or equivalent, 1-2 years experience preferred. Must be 18 years or older. Must have the ability to perform repetitive work and meet ANI Pharmaceuticals standards. Must be able to read, comprehend and follow written and verbal instruction with accuracy. Must have the ability to read, comprehend and follow written and verbal procedures. Must have excellent accuracy/attention to detail. Must have good basic communication and interpersonal skills. Must be able to lift a minimum of 25 pounds. Understanding of GMP requirements is preferred and a plus. Other preferred qualifications include the ability to wear personal protective clothing/equipment and hearing protection where provided and must be able to work varying shifts. Apply Now! | Top QA Specialist I This position will assure the quality of documentation and data, and assigned disposition of batch records for raw materials, packaging components, finished product release and stability documents. This position is also responsible for providing support to the Manufacturing and Packaging operations to ensure relevant procedures are followed and meet cGMP requirements. Position Responsibilities: - Reviews data, including notebooks, data sheets, electronic data, ancillary data, logbooks, etc., as well as reports of results for compliance with corporate SOPs and FDA guidelines. Highlights GMP deficiencies, initiates the required documentation process, facilitates the implementation of corrective actions and monitor the resolution. - Assisting as required in the stability department, with validation activities, and/or annual report assembly. - Performs disposition finished product, raw materials, and packaging components. Performs review of finished product stability data. - Perform packaging line inspection/audits and provide assurance that packaging operations are compliant with applicable SOPs and cGMPs. - Perform finished product attribute sample inspection and evaluation of finished products physical characteristics prior to packaging. - Perform annual retain sample inspections and control finished product and raw material retain samples stored in the reserve sample room. Monitor GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness, per CFR21 Subpart A General Provisions to assure they reflect current practices and meet industry standards and cGMP requirement. - Performs other duties as assigned or requested. Position Requirements: - Bachelors degree and 2 years experience working within Quality Assurance or Quality Control - Good understanding of laboratory testing and raw data, particularly HPLC - Excellent computer skills. - Previous work in a regulated environment - Problem solving skills. - Ability to coordinate multiple tasks in a fast-paced environment. - Ability to read and follow procedures. - Ability to work independently as well as within work within a team environment. - Attention to detail - Excellent interpersonal skills. - Excellent Organizational and follow through skills - Excellent written and verbal communication skills. - Knowledge of cGMP's. - Written and verbal communication skills - Must be able to travel occasionally Apply Now! | Top QC Analyst This position is responsible for independently performing laboratory testing, as defined by governing test methods and standard operating procedures. This is an entry level professional position in the Quality Control Laboratory. Position Responsibilities: - Perform testing on raw material, in-process, and finished product samples. Prepare standards and samples in accordance with approved methods. Set up and confirm suitable operation of equipment and instrumentation. Collect data and generate/report results in accordance with governing test methods and SOPs. - Perform review of data collected under approved test methods. Provide accurate assessments of data integrity, and document findings. - Perform calibrations, preventive maintenance, and repairs as needed on instrumentation. Qualify new equipment as assigned. - Perform cGMP tasks such as laboratory housekeeping, auditing of documentation, and maintenance of reagents and supplies. Position Requirements: Bachelors degree in Chemistry, Pharmacy or closely related field. Experience in an analytical laboratory, academic or otherwise. Ability to coordinate multiple tasks in a fast paced environment. Ability to read and follow procedures. Ability to work independently and under minimal supervision. Demonstrated understanding of good analytical technique. Organization, communication and interpersonal skills. Ability to handle fine glassware, sampling devices and perform data entry. Apply Now! | Top QC Chemist/Sr. QC Chemist The QC Chemist position is responsible for independently performing testing in a pharmaceutical Quality Control laboratory. All work will be conducted in accordance with standard operating procedures and test methods. This includes performing testing on raw material, in-process and finished product samples. Execute compendia method validations, method transfers and validation support of new product development. Set up and confirm suitable operation of equipment and instrumentation. Collect data and generate/report results in accordance with governing test methods and SOPs. Position Responsibilities: Perform review of data collected under approved test methods and investigational plans and protocols, in accordance with governing SOPs. Provide accurate assessment of data integrity, and document findings. Perform calibrations, preventive maintenance and repairs as needed on instrumentation. Qualify new equipment as assigned. Perform cGMP tasks such as laboratory housekeeping, auditing documentation and ordering supplies. Perform other duties as assigned or requested. Position Requirements: - Bachelors degree in chemistry, biochemistry, microbiology or closely related field/major. -QC Chemist - 1-3 years experience, with 2-5 years experience preferred, in a chemistry lab in the pharmaceutical, food, or other closely related industry. -Sr. QC Chemist - 2-5 years experience, with 5+ years experience preferred, in a chemistry lab in the pharmaceutical, food, or other closely related industry. - Ability to read and follow written procedures - Attention to detail. - Ability to work with minimal supervision - Problem solving skills - Organization, communication and interpersonal skills. - Understanding of good laboratory practices and analytical techniques. Apply Now! | Top QC Technician This position is responsible for support of QC testing activities. These responsibilities include: Position Responsibilities: - Washing Laboratory Glassware - Sampling of Raw Materials - Inspection of Packaging Components - Minor Raw Material Testing - Filing of Laboratory Records and Documents - Special Project Assignments - Auditing Samples, Logbooks and Data Records Position Requirements: - High School diploma or equivalent and 0-2 years experience. Associates degree and 2-5 years experience in a QC environment is preferred. - Ability to read, comprehend and apply written and verbal instructions accurately. - Attention to detail. - Problem solving skills - Excellent interpersonal and communication skills. - Excellent organizational and follow-through skills. - Ability to wear personal protective clothing/equipment and hearing protection where required. - Ability to lift up to 50 lbs. Apply Now! | Top Scientist I The Scientist I carries out technical projects as assigned by the head of Product Development. He/she is responsible for formulation and process development associated with technology transfer and/or ANDA projects. Position Accountabilities Position Responsibilities: Primarily responsible for supporting the needs of technology transfer projects and ANDA development projects. - Authors and executes documents such as protocols, reports, batch records, and technical assessments. - Plans experiments and analyzes data. Records data in laboratory notebooks. - Able to use statistics to plan experiments and analyze data (e.g. Design of Experiments, Statistical Process Control, Process Capability) - Evaluates equipment purchases for applicability. - Evaluates physical characteristics of new raw materials. - Provides Manufacturing, Validation, Packaging, and Regulatory Affairs, with technical input. - Maintains Department SOPs. - Assists in training operations on new products/processes. - Effectively communicates cross-functionally Assists with improving department infrastructure and procedures. Helps to develop best practices. Initiates, creates and revises SOPs as appropriate. Assists Manufacturing and Packaging with process and packaging related investigations. Researches and prepares Technical Assessments, as required. Performs other duties as assigned or requested. Position Requirements: Bachelors, Masters or Ph.D. in Chemical Engineering, Chemistry, Biology, or a related life science. -Two years of college or vocational education in a scientific field - High school diploma Experience: - Minimum of 3 years with a M.S., minimum of 5 years with a BS degree, minimum of 12 years with an AS degree, or minimum of 15 years with a HS diploma. - Experience must be in product development, technical services, or other form of manufacturing support. Minimum Field of Expertise: - Ability to coordinate multiple projects in a fast paced environment. - Demonstrated ability to perform in a team environment. - Excellent communication skills - Excellent organizational and follow-through skills - Interpersonal skills - Troubleshooting ability - Understanding of cGMPs Preferred Field of Expertise: - Ability to plan, organize, and implement development project plans and objectives - Demonstrated leadership skills - Previous pharmaceutical industry experience - Previous ANDA development experience - Strong technical writing ability - Familiarity with ANDA submission requirements and related FDA guidance documents (e.g. split tablet evaluation, Quality by Design, stability, etc.) Apply Now! | Top Senior Scientist I The Senior Scientist I independently leads technical projects as assigned by the head of Product Development. This includes responsibility for formulation and process development associated with technology transfer and/or ANDA projects. Position Responsibilities: Primarily responsible for managing technology transfer projects and ANDA development projects. This includes: Authors and executes documents such as protocols, reports, batch records, and technical assessments. Plans experiments and analyzes data. Records data in laboratory notebooks. Able to use statistics to plan experiments and analyze data (e.g. Design of Experiments, Statistical Process Control, Process Capability) Evaluates equipment purchases for applicability. Evaluates physical characteristics of new raw materials. Assists Manufacturing, Validation, Packaging, and Regulatory Affairs, with technical input. Maintains Department SOPs. Assists in Training operations on new products/processes. Provides technical input on investigations and/or CAPAs associated with manufacturing and packaging of marketed products. Identifies process improvements. Performs activities needed to support alternate API filings. Assists with improving department infrastructure and procedures. Helps develop best practices related to marketed product support and/or technical writing. Initiates, creates and revises SOPs as appropriate. Assists Manufacturing and Packaging with process and packaging related investigations. Researches and prepares Technical Assessments as required. Performs other duties as assigned or requested. Position Requirements: This position requires a Bachelors degree with a minimum of 9 years experience, or a Masters degree with a minimum of 7 years experience, or a or Ph.D. with a minimum of 4 years experience. All degree majors are required to be either Chemical Engineering, Chemistry, Biology, or a related life science. AS Degree in a scientific field with a minimum of 12 years experience. A HS Diploma with a minimum of 15 years experience. Experience for all levels of education must be in product development, technical services, or other form of manufacturing support. Minimum qualifications include the ability to coordinate multiple projects in a fast paced environment. Demonstrated ability to perform in a team environment. Excellent communication and interpersonal skills. Excellent organizational and follow-through skills. Troubleshooting ability. Understanding of cGMPs. Preferred qualifications include the ability to plan, organize, implement, and product transfer projects, plans and objectives. Demonstrated leadership skills. Previous Pharmaceutical industry experience. Proven ANDA development experience. Familiarity ANDA submission requirements and related FDA guidance documents (e.g. split tablet evaluation, Quality by Design, stability, etc.) Apply Now! | Top Supervisor, Quality Control This position is responsible for managing and directing, a professional group of analysts engaged in physical and chemical testing of raw materials, packaging components, in-process materials, and finished drug products to determine conformance with specifications. This position is responsible for day to day scheduling of analyst responsibilities to ensure production needs are being met and that the laboratory is in conformance with cGMPs. Additional responsibilities include conducting and writing laboratory investigations, notifying Quality Assurance of potential product quality issues, coordinating contract lab testing, revising SOP's, IOPs and other laboratory related documents. Lastly, this individual enforces company policies and directives that apply to the department. Position Responsibilities: Manage and direct a group of analysts effectively so company goals and objectives are met, provide input on resources availability and needs to support production and project plans/sales goals, and coordinates work schedules with other departments. Develops plans and timelines to assure analytical support. Assures effective and efficient utilization of resources. Establishes work priorities and expectations. Delegates authority and responsibility for the accomplishment of planned work. Provides direction and feedback for timely work accomplishment. Manages external laboratory resources to handle overflow laboratory support. Provides training and enforces policies and procedures. Assures systems and procedures are adequate by developing, reviewing, and approving procedures to assure compliance with governing regulations, filed applications, and quality standards. Identifies deficiencies and implements corrective actions. Provides technical expertise to support investigations, protocols and procedures outside the laboratory. Monitors training, performance and development of professional staff and provides feedback. Performs reviews of data collected under approved test methods, investigational plans, and protocols in accordance with governing SOPs. Approves all analytical data and results and releases to Quality Assurance. Work with analysts to correct deficiencies, mentor to assure understanding. Notifies Quality Assurance in the event of a potential product quality issues and conducts and writes laboratory investigations. Ensures timely implementation and closures of CAPAs. Perform other duties as assigned or requested. Position Requirements: Minimum Education -Bachelor's Degree in Chemistry, Microbiology, or related field. -Education, training, or certification in Management and Leadership Minimum Experience -1 year experience in a leadership role in an analytical laboratory in the pharmaceutical industry. -4 years experience in an FDA regulated laboratory in the pharmaceutical industry Minimum Field-of-Expertise -Ability to follow, prepare and explain technical matters and procedures. -Ability to make decisions independently after appropriate input from areas that will be affected. -Ability to manage multiple projects and competing priorities. -Ability to perform under stressful situations -Demonstrated expertise of Laboratory cGMPs -Excellent leadership, communication, and interpersonal skills. Preferred Education -Advanced education in Management or Business Administration. -Post graduate degree in Analytical Chemistry, or other relevant area. Preferred Experience -3+ years within the Baudette QC Organization. -5 years experience in an analytical laboratory in the pharmaceutical industry. Apply Now! | Top Technician - Product Development The Technician will work in support of development and marketed product support projects including but not limited to formulation and process development, manufacturing of clinical supply, and manufacturing scale-up. Position Responsibilities: This includes learning to assist with manufacturing equipment and processing, material handling, cleaning, batch record execution, packaging, troubleshooting, compiling data, scheduling, physical testing, notebook documentation, ordering supplies, Product Development (PD) lab organization, continuous improvement projects, maintaining Standard Operating Procedures (SOPs), new equipment set-up, batch testing, as well as working within Microsoft Office products such as Word, Excel, and Outlook. Position Requirements: High Scholl Diploma, or equivalent, with 0-2 years of experience. With experience, experience must be in Product Development, Technical Services, or other form of manufacturing support along with familiarity with manufacturing processes and equipment. Additional qualifications include: - Problem solving skills - Must have the ability to read, comprehend and apply written and verbal instructions accurately. - Ability to work in a methodical and organized fashion. - Excellent accuracy/attention to detail. - Must be able to work independently and/or with a team. - Good communication and interpersonal skills - Basic computer skills (email, Word, Excel, etc.) - Demonstrated understanding of professional environment. - Demonstrated willingness to seek and pursue challenging tasks. - Ability to wear personal protective clothing/equipment and hearing protection where required. This position will work in an office environment with frequent interaction in manufacturing/processing/packaging areas and laboratories. It also requires frequent sitting, standing, occasional bending, and light to medium lifting (up to 40 pounds). Flexible schedule based on project needs.