About the position
Our company is expanding its global Bacillus Calmette Guerin (BCG) vaccine production by adding an end-to-end laboratory capability located in the Durham, NC campus. The new facility will be used to produce the bulk active ingredient, finished product, and laboratory testing for the BCG vaccine. The Specialist, Quality Control participates in a team of analysts in the development, validation, and routine testing for the BCG Product. The position will focus on environmental monitoring, aseptic process simulation and support testing readiness in preparation for commercial production. The selected candidate will participate in equipment validation, process validation, and GMP laboratory readiness. The Quality Operations Laboratory Specialist performs laboratory testing on a variety of product samples and media. The selected candidate 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 understanding of Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit support.
Responsibilities
- Collaborate with internal customers and vendors to identify, evaluate, and implement new analytical technologies that expand site capabilities.
- Apply project management concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for new assay development/validation, project timelines and budgeting.
- Build knowledge of the company, processes, and internal/external customers.
- Build and maintain strong relationships with site leadership, stakeholders, and customers.
- Apply team effectiveness skills, listening and integrating diverse perspectives from across the work group; contribute and add value to the achievement of team goals.
- Understand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testing.
- Function effectively within an automated/electronic laboratory environment.
- Sampling of clean utilities including but not limited to compressed gas and water for injection.
- Environmental monitoring of production and support areas, including sampling, processing of samples, and reporting results.
- Participate in Environmental Monitoring Performance Qualification activities.
- Microbiological testing in support of production media.
- Participate in aseptic process simulations, including sampling, testing of simulation units, and reporting of data.
- Schedule daily testing of laboratory samples based on internal metrics and production needs.
- Author/review technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methods.
- Initiate and contribute to laboratory investigations as needed and follow site procedures in the documentation of Quality Notifications and Corrective/Preventative Actions.
- Execute test method qualification.
- Trouble-shoot equipment issues as needed.
- Laboratory maintenance including managing stock of reagents, consumables, and laboratory cleaning.
- Train and mentor laboratory analysts on test methods, techniques, and good documentation practices.
- Review laboratory generated data and results.
- Authorize and approve samples.
- Provide active support during audits and inspections (regulatory, internal, safety).
- Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations.
- Collaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirements.
- Support Manufacturing's Divisional and Quality initiatives.
- Additional project and routine testing support as required.
Requirements
- B.S. in Biological Sciences, with minimum of 3 years of laboratory experience.
- Experience with aseptic manipulations.
- Experience with environmental monitoring activities.
- Experience in sampling of clean utilities, including but not limited to compressed gases and water.
- Good technical writing skills and high attention to detail.
- Previous GMP-laboratory experience.
- Work independently and within a team environment.
Nice-to-haves
- Experience with responding to regulatory questions with multiple agencies (FDA, EMA, JNDA).
- Experience authoring technical documents supporting regulatory filings (IND, BLA).
- Experience with assay development, validation, or technical transfers.
- Equipment Validation.
- 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, laboratory investigations, and method transfer/qualification reports.
- Experience in training of personnel.
