QC Microbiologist
INCOG BioPharma Services are seeking a Quality Control Microbiologist who has a passion for learning, collaborating, and contributing to the success of their clients. The Microbiologist will be dedicated to the success of the Quality Control team, resulting in the production of the highest quality products for their clients.
The Quality Control Microbiologist will work closely with Quality Control leadership and will develop the program for performing microbiological in-process, release, and stability testing of parenteral injectable products and the requisite supporting testing (e.g. environmental monitoring, cleaning validation, incoming QC). The Microbiologist will be committed to operating with a Quality Mindset in every aspect of their role, including attention to detail, on time delivery, and efficiency. There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.
At INCOG, they are more than just a contract development and manufacturing organization. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At our core, that is who INCOG are—a dedicated team that believes they can always be better.
Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients for yourself, INCOG’s clients, and patients.
Job Functions:
- Partner with leadership in the development of a world-class QC platform which will include a robust environmental monitoring program, and laboratory processes that adhere to procedures and regulatory requirements for the evaluation of microbiological aspects of drug products, excipients, and process materials. This includes, at a minimum, tests for sterility, endotoxin, and bioburden.
- Leadership role in partnering with program owners to develop PM and calibration plans to coordinate upkeep, conformity and IQ/PQ/OQ of instruments and laboratory environment.
- Collaborate with the Quality Team on building laboratory safety program to ensure a safe and quality-minded environment for all personnel working in the laboratory.
- Advocate for clients by collaborating cross-functionally to schedule microbiological sampling, testing, instruments, and personnel to meet customer needs and timelines.
- Maintain a constant state of safety and inspection-readiness in the QC laboratories. Use knowledge of quality principles, cGLPs, cGMPs, and regulatory standards to act as a key point-of-contact for regulatory agencies during inspections and audits.
- Support laboratory investigations using troubleshooting tools to identify errors, and exercise rapid decision making to implement corrective actions during OOS/OOT and other non-conformance events.
- Utilize various paper and automated systems to manage local QC and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.
Candidate Requirements:
- 2+ years of microbiology, biology, or other related experience.
- Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control.
- Experience with using laboratory instrumentation that analyzes sterility, endotoxin, and bioburden.
- Exceptional computer skills evidenced by hands-on work with automated data management. and/or data analysis systems (LIMS, JMP, minitab, etc.).
- B.S. in Biochemistry, Biology, or Microbiology.
Why INCOG?
- Paid time off, based on tenure
- 11 paid holidays
- 401(k) plan with company match up, vested immediately
- Choice of health & wellness plans
- FSA and HSA options
- Onsite wellness facility
- Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…
Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
