Msd
Senior Specialist, Quality Assurance (Hybrid)
USA - New Jersey - Rahway · Senior · Contract
Sponsorship not specified$106k-$167kDetected 1 day ago
NegotiationSAPHRISCustomer SupportGMPCommunicationCollaborationProblem SolvingGxP
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Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70
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About the role
- Job Description The Biologics Development Quality group in Rahway (BDQR) within Global Development Quality is responsible for technical, operational and quality oversight of a growing and fast-moving large molecule pipeline.
- BDQR is specifically focused on quality oversight for large molecule drug substance process & analytical development, GMP clinical manufacturing, and the testing & release of clinical supplies.
- Please click here if you need an accommodation during the application or hiring process.
Responsibilities
- Support operational readiness by partnering cross-functionally to enable compliant start-up and execution of GMP activities.
- Apply a quality-by-design mindset by supporting appropriate use of quality systems, procedures, and documentation controls through planning, execution, and routine operations.
- Build and maintain effective partnerships with key stakeholders to provide Quality guidance, support timely decision-making, and contribute to oversight of quality events, including deviations, change controls, CAPA, and audit support.
- Manage the review and/or approval of analytical and process GMP documentation for applicable regulatory filings, clinical supply, development, and technology transfer.
- Review and approve analytical and manufacturing documents.
- The Senior Specialist, Quality Assurance BDQR is responsible for providing Quality oversight and technical support for analytical and process development activities supporting large molecule programs, while ensuring compliance with cGMPs, applicable worldwide regulations, and our Company requirements for supported area(s).
- The Senior Specialist applies a strong Quality mindset, partners with stakeholders, and supports compliant execution and decision-making across routine operations and quality events.
- Maintain a proficient level of knowledge related to areas of technical expertise.
- Manage the clinical release or re-evaluation dating to ensure conformance to appropriate worldwide regulatory requirements.
Requirements
- Minimum of 5 years of experience in Pharmaceutical / Biotechnology industry role(s) with a BS, or 3+ years with an advanced degree.
Nice to have
- Preferred Skills:
Skills
- Experience in Biologics Quality, Biologics Manufacturing, and/or related functions at pilot and/or commercial scale.
- Strong knowledge and application of Current Good Manufacturing Practice (cGMP).
- Interpersonal skills in verbal and written communications, collaboration, teamwork, negotiation, and conflict resolution.
- Experience with quality risk management.
- Experience supporting cross-functional teams and contributing to problem-solving situations.
- Strong knowledge of biologics manufacturing processes, biologics analytical method validation and testing, and regulatory requirements.
- Experience in facility start-up and GMP Operational Readiness or clinical supply areas and processes.
- Biopharmaceutical Industry, Deviation Management, GMP Compliance, Quality Assurance Systems
- Current Employees apply HERE
- Current Contingent Workers apply HERE
- Preferred Experience and
- US and Puerto Rico Residents Only:
Compensation
- The salary range for this role is
Equal opportunity
- Employment laws, visit:
- EEOC Know Your Rights
- EEOC GINA Supplement
- We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Visa & Work Authorization
- VISA Sponsorship:
This listing is sourced directly from Msd's careers page and normalized into a canonical job model.