Biological Quality Assurance Specialist

3 weeks ago


Hanover Hills, Maryland, United States Disability Solutions Full time

The role of a Biological Quality Assurance Specialist at Disability Solutions involves providing dedicated QA support to client projects and client interactions & meetings. This includes quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product. The successful candidate will be involved from inception of a client's project until project closure, supporting Clinical and Commercial QA activities, including initial process development and non-clinical batch production.

Key responsibilities include tracking, documenting and presenting Quality Metrics presentations for Client Projects (on time batch release, right first time, deviations per batch). The ideal candidate will work with clients during initial and subsequent manufacturing campaigns, conducting review of master batch records during Technical Transfer for client processes. Additionally, they will support GMP departments in reviewing and approving deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and evaluating effective corrective and preventive actions (CAPAs).

The anticipated salary range for this position in Maryland is $93,280-$128,260 plus an annual bonus target. We offer competitive medical benefits and 401K, 152 hours PTO + 8 Paid Holidays, and a dynamic, fast-paced work environment. As a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide, we are committed to excellence in quality and compliance, and to the safety of every patient, consumer and employee.

We are looking for a creative individual with excellent analytical, trouble shooting, and decision-making skills, knowledgeable about Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs. Familiarity with electronic systems, including developing and producing reports using Microsoft products, such as LIMS, Master Control and Trackwise knowledge is preferred.

This role offers the opportunity to work on Continuous Improvement Processes, and to be part of a global drug development and delivery leader that helps bring over 7,000 life-saving and life-enhancing products to patients around the world. At Disability Solutions, we value personal initiative, dynamic pace, and meaningful work.



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