Sr. Spclst, Quality

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

The Quality Operations Laboratory Specialist performs laboratory testing on a variety of product samples, including bulk vaccine, filled vaccine, and media.  The successful candidate will support the microbiology testing laboratories with emphasis on microbiological methods such as sterility, bacteriostasis/fungistasis, Neomycin potency, Mycoplasma, and Mycobacteria.  The analyst will also be expected to review and authorize testing results, collaborate in day to day lab scheduling, provide leadership in lean lab initiatives, have a strong understand of Labware LIMS, handle Quality Notification authoring and provide audit support. 

• Schedule daily testing of laboratory samples based on internal metrics and production needs.

• Serve as the Microbiology subject matter expert for internal and regulatory inspections.

• Participate in routine audits of Quality Operations laboratory to ensure compliance and inspection readiness.

• Train and mentor laboratory analysts on microbiological test methods, techniques and good documentation practices.

• Author and execute test method qualifications and final reports for microbiological assays.

• Has knowledge of cell culture propagation and maintenance procedures, and/or microbiological laboratory procedures

• Authors standard operating procedures (SOPs) for the performance of laboratory methods

• Trouble-shoots equipment issues as needed

• Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Preventative Actions

• Collaborates with Durham Laboratory Compliance to ensure adherence to regulatory requirements

• Provides active support during audits and inspections (regulatory, internal, safety)

• Supports our Manufacturing Division divisional and Quality initiatives

Qualifications

Required:

• B.S. or M.S. degree in Biological Sciences, with minimum of 5 years of laboratory experience

• Experience with aseptic manipulations

• Exceptional pipetting techniques

• Good technical writing skills and high attention to detail.

• Experience with execution and trouble-shooting of cell based and other microbiological/biological assays.

• Previous GMP-laboratory experience

• Work independently and within a team environment

• Sterility testing (compendia or rapid microbiological methods) experience

• Experience with compendial microbiological testing such as (USP Chapters <61>, <62>, and <85>)

• Experience with assay development, validation, or technical transfers

Preferred:

• Experience with responding to regulatory questions with multiple agencies (FDA, EMA, JNDA,).

• Equipment Validation

• Root cause analysis methodology

• Knowledge of CFR, Eudralex, and Compendia testing specific to the pharmaceutical industry

• Experience in regulatory agency audits and/or regulatory filings

• Experience in technical writing, including Standard Operating Procedures and method transfer/qualification reports

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientatio