Job Description

QA SPECIALIST - SIMPLY BIOTECH

Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.

Immediate opening for a QA Specialist at our client, an “essential business”, located in San Diego, CA who possess:

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or related science
• 3+ years of GMP experience in the pharmaceutical industry
• Quality Control experience in addition to quality assurance is a plus

Email your resumes to rmontillo@simplybiotech.com or call 858.633.2357

FULL DESCRIPTION: THE QA SPECIALIST IS RESPONSIBLE FOR DOCUMENT CONTROL FUNCTIONS, ISSUANCE OF CONTROLLED DOCUMENTS, UPDATING OF SOP BINDERS, MAINTENANCE OF TRAINING RECORDS AND SENDING OF TRAINING NOTICES, ASSIGNMENT OF TRACKING NUMBERS, SUPPORT FOR CLIENT AND REGULATORY AUDITS, DOCUMENTATION SUPPORT FOR CLIENT AND REGULATORY AUDITS, AND PERFORMANCE OF INTERNAL AUDITS.

The selected candidate will be responsible for the following:

Document Control:

• Processing of change controls for new and revised documents using the company’s document management system. Ensure that document reviewers are properly assigned, and review timelines are met, edits to documents are performed properly and revisions histories accurately represent the changes made.
• Ensure that controlled document binders, if used, are updated with new/revised SOPs and outdated controlled documents are removed from binders. Responsible for ensuring that the SOP table of contents is always current.
• Processing and management-controlled documents through the company’s document management system. Migrating of older paper copy controlled documents into the company’s document management system. Assignment of tracking numbers, tracking of document status, circulation of document for review and approval, effective dating of documents.
• Prepare monthly quality metrics and electronically disburse to employees to increase awareness and prevent recurrences [CAPA, Deviation, OOS, document review errors, etc.]
• Elevate quality systems issues to senior management, provide itemized list of potential solutions to the issues, carry-out approved solutions by authoring or revising SOP’s and implementing other changes to reduce or eliminate similar issues in the future.

Training:

• Following approval of the document, the QA specialist is responsible for ensuring that training notices are sent to employees and that than training is completed.
• Responsible for ensuring that hard-copy training records are filed according to the company’s procedures in employee training files and for ensuring that training files remain in a state of audit-readiness.
• Maintain the schedule for annual GMP training, coordinating of training dates with staff members, and ensuring that attendance sheets are completed by each person in attendance. Responsible for archiving a copy of the GMP training presentation with training documentation.
• Coordination of safety training of staff members for sessions involving environmental health and safety, fire extinguisher training, evaluation training, etc.
• Ensure training notices are sent to affected employees, ensure that training records are completed according to SOP requirement, maintenance of the company’s training record filing system.

Assignment of Tracking Numbers:

• Responsible for completion of Quality Assurance logbooks for the assignment of numbers for deviations, CAPAs, batch records, test methods, equipment, product lot numbers, etc.

Support for Client and Regulatory Audits:

• Provide on-going support for client and regulatory audits including, but not limited to, triage of requested documentation, providing context and historical perspective to the documentation to lead the company’s audit host, coordinating the company’s staff for interview by auditor, author written responses to audit observations to QA management for review prior to sending to the client or regulatory agency.
• Responsible for providing support including locating, inspection, and delivery of requested document to the audit room.
• Notifying staff members when their presence is requested by the client or regulatory agency during audits.
• Coordination with internal staff members to make necessary corrections to document that are identified during the audit.
• Perform the functions of note taker/scribe during audits if requested by QA management.

Support for Calibration and Preventive Maintenance of Equipment:

• Responsible for review of calibration certificates for compliance with SOP requirements and equipment specifications. Maintain an accurate and complete equipment file for each piece of equipment
• Notification of QA management and the department equipment owner of all “as-found” calibration failures. Assignment of investigation numbers and management of the tracking system for completion.

Internal Audits:

• At the request of QA management, perform internal audits of the company’s quality systems and records for GMP laboratories, manufacturing, facilities and shipping/receiving

QA Main Support:

• Provide QA support for manufacturing operations including: performance of line clearances, Quality Assurance governance / inspection of manufacturing operations in the GMP manufacturing suites, review of master and executed batch records, ensure compliance with the company’s documentation requirements, ensure production deviations and CAPASs are initiated and closed out.
• Review of raw material testing results in compliance with specifications. Release/rejection of raw materials and status labeling of material containers.

For immediate and confidential consideration, please email your resume to rmontillo@simplybiotech.com or call 858.633.2357

More information can be found at www.SimplyBiotech.com

Company Description

Recruiting is a lost art. We’ve brought it back to the basics. Here’s how. Helping People Succeed. As a part of the TalentZök family, we focus on helping you identify the best talent. Whether you’re seeking temporary help or help on a direct hire basis, Simply Biotech and the TalentZök family of companies can connect you to the right person for the job. Biotech. It’s all we do. We believe that effective and successful recruiting must be specialized. It is the only way to truly know both companies and job seekers and the most effective way to bring them together. At Simply Biotech, we focus only on the biotech/device industry. No “resume farming” here The most talented people rarely post their resumes to job boards. They are out there working, untapped. Many don't even know they are interested in better opportunities because they are passive job seekers. You want the best person for the job and chances are, the best person doesn't have their resume posted. They may even be working for your competitor. So searching the job boards along with every other biotech firm won't get you the result you're looking for. Only old-fashioned recruiting - picking up the phone, networking and finding the talent in the workforce - will get you the perfect match. Thank you for calling We've picked up that old book on customer service, dusted it off, and put it back into practice. How many times have you left a message and never heard back? At Simply Biotech, customer service is our priority. We return calls promptly. We don't let you fall through the cracks. It sounds so simple yet so few know how to do it right. We do our homework - to save you time Before filling a position, we speak with many of the people involved in making the decisions and ask quite a few questions. While this takes a little longer in the beginning of the process, it allows us to better understand what’s most important in a candidate. That way, we send only qualified candidates who will be in line with what you’re looking for. Many recruiters just forward resumes to clients. At Simply Biotech, we conduct a thorough interview with each candidate before presenting them to you. We speak with them about their experience at each position and find out who they reported to, what their responsibilities were, and why they left. Many times this uncovers information that is omitted in the resume and that may be vital to your decision. We feel that it is our responsibility to thoroughly screen candidates before presenting them to you. This process results in fewer, better candidates for you to consider - and saves you time.