QC Specialist - EM and Micro Testing
About The Position
Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. The QC Lab at Bionova is seeking a self-motivated, innovative, and team-oriented QC Analyst with strong technical and communication skills to support microbiology testing of biologics. In this role, you will contribute to a dynamic and expanding business as part of a rapidly growing Quality Control team. You will have the opportunity to influence decisions, collaborate cross-functionally, and develop your own skills while working toward project goals that ultimately improve patient outcomes.
Requirements
- Bachelor's Degree or above from an accredited institution in Microbiology, Biology (or closely related degree).
- Requires 4+ years of quality pharmaceutical, bio-pharmaceutical, or combi-medical device experience, and analytical testing experience on Biologics.
- An energetic scientist and a creative thinker who can explore and identify better and more efficient methods to address issues and gaps.
- Demonstrate ability to work independently and on cross-functional teams.
- Strong attention to detail and following procedures and requirements.
- Effective verbal and written communication skills.
- Great interpersonal and teamwork skills.
- At least 2 years of Technical Writing skills such as SOP, CAPA, deviation reports etc.
Responsibilities
- Perform microbiology testing for routine EM, release, stability, and method verification samples.
- Read plates from environmental monitoring and media fill.
- Perform growth promotion, and Gram Staining.
- Perform endotoxin, TOC, and bioburden testing.
- Enter data in electronic systems and LIMS.
- Manage and orders supplies as needed for testing.
- Assist in QC team implementation of GMP procedures, processes, and systems.
- Train QC staff on instrumentation, techniques, microbiology methods.
- Initiate trend reports.
- Author/review/approve technical documents such as method qualification/validation/transfer protocols and reports, and regulatory filing documents per project needs.
- Initiate/Investigate deviations, Change control and CAPA.
- Maintain lab equipment as appropriate per procedures.
- Contribute to investigation of issues and non-conformities to products and projects and perform troubleshoot of equipment and testing procedures to identify root causes of issues and participate in lab investigations.
- Help in maintaining the QC lab in a clean, organized and compliance at all times.
- Perform other QC tasks as required.
Benefits
- Bionova offers health benefits at a subsidized rate.
- Healthcare, Dental, and Vision insurance
- Life Insurance and Disability Program: 100% covered by Bionova.
- Retirement Plan (401K)
- Up to 8% of Employer Match
- Paid time off up to two weeks
- 10 days of Holidays and 5 days of Sick Leave.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
