Summary: Cambrex (www.Cambrex.com) is seeking a highly motivated, energetic, results-oriented individual to join our team of dedicated professionals focused on customer service and quality. We are currently accepting resumes for the position of Analytical Data Review Scientist.

About the Job:

This position will be reporting to the Quality Assurance department and supports the GMP Analytical laboratory.  The GMP Analytical laboratory provides analytical services to both GMP and non-GMP manufacturing by supporting development and validation of analytical test methods, evaluation and testing of cleaning samples, raw materials, process intermediates, final APIs, and final dosage forms, characterizing/qualifying Reference Standards, and performing Stability evaluations. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, and regulatory requirements.

Responsibilities:

• Ensures the quality of laboratory data and reports. Efficiently and effectively reviews chromatographic/other data and related notebooks as specified by Standard Operating Procedures (SOPs). Evaluates data to ensure compliance with analytical methods, client criteria, and Good Manufacturing Practices (GMP).
• Must be able to understand and interpret analytical data (chromatographic and other). Scrutinizes and fully fathoms routine and non-routine testing/other data in order to ensure compliance, accuracy, and completeness of work as well as veracity of results based on documented data.
• Must be able to critically and in detailed fashion review/verify Reports, SOPs, Specifications, Analytical procedures, etc. Example: Reviews sample results tables and analytical reports for completeness and accurate representation of the data and report findings.
• Must be able to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
• Must be able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Organizes workflow and tasks to maximize efficiency (e.g., prioritize review/writing based on client/business needs, etc.).
• Demonstrated ability to work with others at all levels of the organization and have basic knowledge of computers and industry-related software.
• Ability to work effectively under pressure to meet deadlines
• Ensures compliance with company policies and SOPs as well as FDA and other applicable guidelines.

Minimum Requirements:

The successful candidate will hold a minimum of a Bachelor’s degree in Chemistry, Biology, Microbiology, or closely related discipline, and 4 years relevant pharmaceutical laboratory/analytical experience, including a minimum requirement of 2 years of data review experience.

This candidate will have a broad background in analytical methodology, strong comprehension, and demonstrated skills in review of analytical and compliance oriented data and documentation. Strong attention to detail is a requirement. Thorough knowledge of SOPs, cGMPs, and Federal Regulations are a strong positive. Prior HPLC/GC/Other Instrumental experience is required. Certified Quality Auditor or similar is a strong plus. Hands-on experience in technical writing is a plus.

Other Experience/Skills: In-depth work experience in an analytical contract laboratory environment is a strong positive. Experience in stability study performance/evaluation is helpful. Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential. Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected.

Please send all resumes to:

Cambrex

Attention: Human Resources

4180 Mendenhall Oaks Pkwy

High Point, NC27265

Cambrex offers Custom organic synthesis, cGMP scale-up, Contract research, Molecular building blocks, Medicinal chemistry services and is a leader in fostering the commercial development of small molecule drug discovery and development in pharmaceutical, discovery platform, and biotechnology companies. The Cambrex offering parallels the drug discovery process and provides significant advantages at each step from lead discovery to lead optimization, chemical synthesis and scale-up of pharmaceutical intermediates as well as chemical process R&D.

At Cambrex, we recognize people as our most valuable asset. Our competitive salary and benefits package includes 401K, dental insurance, medical insurance, disability benefits, life insurance, a vision-care plan, paid sick time, casual dress, paid company holidays and paid vacations.

CAMBREX IS AN EQUAL OPPORTUNITY EMPLOYER.

Required Skills Required Experience

Minimum of 4 years progressively responsible experience working in a in a related technology environment. Experience with Lecture Capture technology is highly preferred. Bachelor's Degree required. Master's Degree in related discipline preferred. Certified Technology Specialist (CTS) certification preferred. Must hold a valid driver's license. Must be able to lift moderately heavy equipment (up to 75 pounds). Technical Expertise: Strong experience with lecture capture technology (Echo360 experience preferred.) Equipment expertise includes LCD and/or DLP projectors, visual presenters, audio amplifiers and mixers, various audio and video switching devices and electronic control systems. Experience with sound reinforcement and lighting set ups. ITIL Foundations Certification preferred. Working knowledge of digital signage solutions such as Visix. Working knowledge of video streaming platforms, video network delivery methods, video presentation layers and technologies, video streaming protocols (i.e. RTP, UDP, RTSP, HLS, RTMP, MPEG-DASH), and video codecs (i.e. H.264, MPEG2, vp8, ProRes) required. Knowledge of TCP/IP, LAN/wireless networking principles and application protocols, i.e. HTTp, HTTPS, SMTP, and FTP. Familiarity with remote assistance technology (i.e. Bomgar) and enterprise management software (i.e. Crestron Fusion).Working knowledge of media management systems such as Kaltura. Experience supporting computer hardware and software including Windows

and OSX operating systems, desktop business applications, various specialized applications, peripherals and mobile devices. Experience with WordPress and web site content management and development.

Soft Skills: Must follow procedures and keep accurate records of incidents and requests while working in the field. Strong writing and organizational skills required. Demonstrate patience when problem-solving complex technical issues, Learn and support new technology quickly. over the phone and in person, with diverse customers. Must possess excellent interpersonal communication skills. Strong customer service skills absolutely necessary. Energetic, self-directed, motivated and professional individual who thrives in a fast-paced, dynamic environment. Interact with all levels of an organization in a professional, diplomatic and tactful manner. Work well with external vendors. Work well with both primary and dotted line reporting in a matrix environment. Work productively in cross-functional teams and/or resourcefully and independently as an individual. Must possess the ability to work autonomously and maintain control in rapidly changing situations. A high level of independent decision making is absolutely required.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. We are a VEVRAA Federal Contractor.