Senior Quality Assurance Specialist- Somerset NJ 08873
Candidate must possess expert knowledge of the cGMPs in the Quality Assurance of oral solid dosage units. Candidate must be flexible, have well-developed organizational skills, and can interact with all levels of management. Candidate must be a self-starter, results-oriented individual with ability to articulate, receive, disseminate, and analyze data.
Manage QA Operations/Plant Quality Assurance programs.
Responsible for establishing and maintaining systems to ensure compliance with all applicable regulations.
Work with customers having products developed/manufactured at the site in defining Quality systems specific to product or services being rendered.
Review and approve master and production batch records.
Support the site program for equipment cleaning verification and equipment usage.
Provide oversight for the raw material release program.
Author, review and approve site SOPs.
Monitor and oversee the DEA Program including manufacturing and analytical activities as per CFR 21 Part 1300 series.
Support, Regulatory, DEA, Internal and Customer audits of the facility.
Ensure that written responses are provided and appropriately address the observations for customer audits, internal audits, corporate audits, and regulatory inspections and the responses are completed as committed.
Manage the Deviation Management Excellence (DME) program for the site.
Review and approve Deviations, Non-conformances, Customer Complaints, CAPAs, EOALS, Change Controls, OOS, Atypical/Aberrant and product investigations.
Monitor and oversee the CAPA program, trends, findings, and evaluate CAPA effectiveness.
Hold regular CAPA meetings with the appropriate departments to ensure completion of CAPAs and their effectiveness.
Monitor, assess, and report on Trackwise Problem Reports - CAPA, Change Control, Deviations, Follow-ups, and Tasks etc. by meeting with senior level management team on a regular basis.
Ensure that weekly Trackwise meetings are held and that PR owners obtain resolution for open PRs in a timely manner.
Ensure that the Trackwise SOPs for all quality systems are current and are being followed by the site as stated.
Monitor and oversee Annual Product reviews.
Oversee and manage the SSC team including sample/ finished product storage and annual product sample review.
Oversee the incoming raw material sampling program.
Manage the Compendial Review program
Roll out new Compliance programs for the site: creating SOPs and performing training for these programs.
Provide department quality metrics and tracker information to Senior Management monthly and upon request.
Approve department procedures and assist in the development of new procedures and/or revisions of existing procedures as required.
Oversee the Change Control Program ensuring that it meets current regulatory requirements.
Contribute to process improvement initiatives and represent QA on project teams, management meetings, and other internal forums.
Oversee the Annual Product Reviews.
QA Review and approval of protocols, risk assessments, final reports and qualification documents.
Participate in customer project meetings, customer complaint meetings, and PR meetings as required.
Provide timely and accurate reports and assessments of problems or potential problems to the Director, QA.
Maintain responsibility for interpretation and implementation of CGMP¿s and other FDA regulations and pronouncements.
Provide staff members with leadership, guidance, mentoring, coaching, and feedback against performance and development objectives.
Assign project assignments to staff members with appropriate due dates for project completion.
Education: Candidate must have a BS degree in Chemistry, Microbiology, Pharmacy, or related Science. A Bachelor’s degree with appropriate experience in the Pharmaceutical Industry is desired. Master’s degree is preferable.
Minimum of five (5) years of experience working in Quality areas in the pharmaceutical industry with progressive management responsibilities. Experienced working in a cGMP management role with an understand of compliance and DEA regulations.
Full understanding of FDA and EU CGMPs and DEA regulations pertaining to clinical trial and commercial activities. Good understanding of statistics and audit techniques.
Must be well organized and can multitask.
Thorough knowledge of CGMPS, ability to evaluate facilities records, processes, procedures and practices for conformance to these requirements.
Good mathematics skills.
Good Computer skills, including in depth knowledge of MS Office software package.
Safety procedures associated with the department.
Read and understand MSDS requirements and restrictions.
Understand procedures related to Document Control, Quality Assurance and this job function.
Requires a good understanding of drug manufacturing and laboratory operations.
Experience with performing CGMP audits.
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