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Senior Specialist, Quality Assurance id-637

Job Description

 

Job Description:

The Rahway based Senior Specialist, Global Development Quality Operations - API , is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release, and maintenance in support of our company's clinical supply programs. This person will also independently review and approve documentation accompanying the disposition of API materials (including new modalities such as ADCs) to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory inspections. Independently performs audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our Company procedures. The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs and our company's procedures to assure API (including new modalities such as ADCs) manufacturing and testing is in compliance and will gain competency in their responsibilities.  

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Primary responsibilities include but are not limited to the following:

  • Perform quality assurance activities related to API (including new modalities such as ADCs) manufacturing in a complex, clinical supply development. Review and/or approve GMP documents.

  • Ensure all APIs (including new modalities such as ADCs) are manufactured in compliance with cGMP and regulatory filings.

  • Perform independent quality review and approval of batch records, testing data, and related documents required to release or reject product. Make independent batch release or reject decisions.  

  • Conduct independent auditing, review, and approval of diverse and complex document types, as required, including deviations, investigations, change records, analytical method validations, method transfers, analytical methods, specifications, certificates of analysis, etc. 

  • Accountable for all assigned projects and communication of status to the Management Team.

  • Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels.

  • Establish, educate, and enforce standard operating procedures (SOPs) required under GMP.

  • Develop/update SOPs to ensure practices are accurately reflected. Assist in SOP and quality-related system document approval.

  • Support metrics by summarizing findings during documentation reviews.

  • Collect, prepare and analyze data to support quality system metrics and planning.

  • Support compliance activities such as site readiness, audits, inspections, and CAPAs.

  • Support quality risk management activities as facilitator, project lead and/or quality subject matter expert.

  • Proactively identify, execute and manage independent projects for continuous quality improvement and efficiency.

  • Support the implementation of the clinical supply QMS through participation as topic team member and/or subject matter expert.

  • Represent Development Quality on inter-departmental and cross-functional teams, ensuring communication of information and providing quality guidance and/or deliverables.

  • Exercise broad judgment in making quality decisions and solving complex problems. Escalate issues as needed.

  • Provide meeting coordination, facilitation, scribing, and communication.

  • Other duties as assigned by manager for the flexible functioning of the work group.

 

Education Minimum Requirements:

  • Bachelor's degree (BS) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology). Minimum of 5 years' experience with a BS

 

Required Experience and Skills:

  • Experience in the pharmaceutical, biotechnology, chemical, medical device, or closely related industry. 

  • Experience in one or more functional areas such as quality assurance, laboratory, manufacturing, production, equipment/facilities management, regulatory.

  • Good Manufacturing Practice (GMP) or related small molecule API regulation knowledge and expertise.

  • Strong leadership, collaboration, teamwork, negotiation, communication, problem-solving and workload management skills.

  • Excellent verbal and written communication including presentation skills.

  • Demonstrated ability to manage projects, priorities, to meet deliverables and timelines.

  • Attention to detail, flexibility, and an awareness of production and associated quality problems.

  • Ability to work in a dynamic environment with rapidly changing needs.

  • Ability to work across functional and sites, with all levels of staff and management. 

  • Qualified candidates should have proficiency with Microsoft Suite (Word, Excel, PowerPoint, Teams, etc.) and ability to adapt to learning other electronic systems to support day-to-day work.

 

Preferred Experience and Skills:

  • Knowledge of R&D or clinical supply areas and processes. 

  • Small molecule API knowledge and experience.

  • Large molecule drug substance regulation knowledge.

  • Large molecule Antibody Drug Conjugate (ADC) manufacturing experience.

  • System knowledge of Veeva, SAP, Trackwise.

  • Experience with manufacturing and analytical investigations and CAPAs.

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