QA Investigations Lead job in Raritan, USA

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a QA Investigations Lead with a pharmaceutical company located in Raritan, NJ. The QA Investigations Lead has the responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and complaint product supply.

Job Responsibilities:

Support compliance activities for site Quality Operations in accordance with company standards, procedures and cGMPs
Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues
Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints
Review and approve manufacturing procedures
Support regulatory inspections and audits by ensuring inspection readiness within facility
Perform internal housekeeping audits
Perform analysis on quality indicating data and identifying trends
Provide oversight for trending of quality compliance metrics
Work in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning

Skills and Requirements:

A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required
A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices
Great attention to detail and ability to follow the procedures
The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision
Good written and verbal communication skills are required
Ability to summarize and present results, and experience with team-based collaborations is a must
Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk
Must exhibit strong leadership skills and effectively develop others
Ability to collaborate well with stakeholders, customers and peers
Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality
Must be able to discern the criticality of issues and to communicate to management regarding complex issues
Ability to manage conflict and issues that arise with internal or external customers

If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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