QA Associate II, Operations - Full-time / Part-time

As part of the Quality Assurance team supporting OBI-1, a biologic drug for the treatment of hemophilia, the Quality Associate is responsible for identifying and assessing regulatory and quality risks in activities and processes, in compliance with regulatory agency rules and Baxter rigorous quality practices

*Improve current practice to reduce cycle time using real-time review of batch records within the core manufacturing suite.
*Responsible for reviewing pertinent documents, records and reports such as, Manufacturing Batch Records, lab test results, etc. against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on Good Documentation Practices, regulatory requirements and internal guidelines, etc.
*Responsible for QA issuance and verification of the working cell bank.
*Responsible for completing batch package release for drug substance and product, including communication of timelines and actions with other CMO sites.
*Serve as a Subject Matter Expert (SME) for the Quality organization by reviewing and approving technical documents such as, engineering, validation, stability, development studies, etc.
*Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Division, Plant and other regulatory requirements.
*Determine the logic, adequacy and effectiveness of Quality processes, systems and related requirements. Develop plans to correct identified risks including areas of non-conformance.
*Provide training to local employees on relevant Quality and compliance area(s).
*Participate in external assessments and audits by evaluating and solving product/process problems by providing technical and analytical skills.
*Support process with timely closure of observations/audit items.

Qualifications:

BA/BS (Science or Engineering) required.

Minimum of 3 - 5 years of experience in the Quality function within a CGMP biotech or pharmaceutical manufacturing facility or other similarly regulated industry.

*Must have demonstrated knowledge of FDA regulations, specifically the application of Good Manufacturing Practices.
*Strong knowledge of manufacturing processes and the impact of deviations on the quality of the product.
*Strong computer experience utilizing industry standard Quality systems (Trackwise, ISOtrain, MS Project). Advanced Excel skills are also a plus.
*Strong interpersonal skills and great attention to detail are necessary.
*Must be a strong team player with good problem solving, and good verbal and written communication skills, and the ability to multiple, rapidly-changing priorities.
*Professional quality certifications a plus (CQA, CQE, CQM, RABQSA).

The scheduled for this position is four 10-hour days (Wednesday-Saturday, 9:00 a.m. - 7:30 pm); Occasional flexibility in this schedule may be required depending on the site's manufacturing schedule.

About Aerotek:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 844 895-8598 or email . However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.