Senior Quality Assurance Analyst
1 week ago
About Us
Pace Life Sciences is dedicated to enhancing global health and safety. We support the pharmaceutical and biopharmaceutical sectors by facilitating the drug development journey, from initial research and development through clinical trials to GMP commercial product assistance. For clients with internal manufacturing and laboratory facilities, Pace offers professional services to bolster their operations.
Job Overview:
The selected candidate will oversee laboratory operations that contribute to process development and industrialization, ensuring the thorough characterization of mRNA. This role encompasses various analytical techniques, including HPLC, ELISA, qPCR, and western blot, all vital for process advancement.
Key Responsibilities:
- Conduct analytical evaluations and data assessments of batch release, in-process, and stability samples of mRNA drug substances within a cGMP-compliant laboratory.
- Implement routine procedures utilizing biochemistry methodologies, such as HPLC, UPLC, and SoloVPE.
- Carry out standard procedures based on bioassay methodologies, including plate-based assays (ELISA, ddPCR, ribogreen), gel electrophoresis, western blot, and cell-based assays.
- Assist in laboratory startup initiatives and engage in validation processes.
- Draft revisions to Standard Operating Procedures (SOPs) for managerial review and approval.
- Perform troubleshooting with minimal oversight from supervisors or senior team members.
- Serve as a trainer for specific methodologies, guiding less experienced analysts in their areas of expertise.
- Support qualification and validation testing of Quality Control methods in your area of specialization.
- Lead and/or assist in laboratory investigations.
- Contribute to the ongoing enhancement of laboratory safety and quality compliance.
- Participate in the development of innovative methods and processes.
- Engage in general laboratory tasks and equipment management, including pipetting, solution/sample/media preparation, and operation of pH meters, autoclaves, and analytical balances.
- Maintain laboratory cleanliness and manage supply inventory.
Qualifications:
Education and Experience:
- Bachelor's or Master's degree in analytical chemistry, biochemistry, or biotechnology, or equivalent.
- Bachelor's degree with a minimum of 3 years or Master's degree with no prior experience in the vaccine or pharmaceutical industry, specifically in QC analytics or R&D.
- Preferred: 2 years of experience in cGLP or cGMP laboratory settings.
- Proficient in biochemical and bioassay techniques.
- Familiarity with laboratory software (LIMS, Empower, Bio-Rad Image Lab).
- Understanding of regulatory standards applicable to cGMP laboratories.
- Strong verbal and written communication skills.
- Experience with Microsoft Office 365.
- Ability to employ deductive reasoning and demonstrate initiative in problem-solving.
- Capable of managing multiple tasks simultaneously, self-driven, and results-oriented.
About SIS at Pace
Aligned with Pace's mission, our clients are consistently innovating and seeking quality professionals to support their critical initiatives. As a member of the Pace Scientific Insourcing Solutions team, you will have the opportunity to collaborate directly with industry leaders who have scientific needs both within and outside of the laboratory.
Additional Information
Benefits:
We offer a comprehensive benefits package, including 80 hours of paid vacation annually, 7 paid holidays, 2 floating holidays (prorated based on start date), 40 hours of paid sick leave, paid bereavement leave, 8 hours of paid volunteer time, medical, dental, and vision insurance, voluntary short-term and long-term disability, life insurance, a traditional and ROTH 401k with company match, HSA, FSA, employee referral bonuses, tuition reimbursement, employee recognition programs, and various voluntary insurance options.
Equal Opportunity Employer
Pace is committed to providing equal employment opportunities to all employees and applicants, prohibiting discrimination and harassment of any kind based on race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms and conditions, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Work Schedule: Monday to Friday, 8 AM to 5 PM
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