Senior QA Lead: Compliance & Manufacturing Excellence

Mcneil Ab; Puerto Rico; Hybrid; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Kenvue is seeking a Senior QA Supervisor to lead quality assurance operations at the Las Piedras site. You will oversee QA activities, approve change controls, CAPAs, and product dispositions, and ensure cGMP compliance.

The role involves coordinating with upstream/downstream areas and guiding QA staff. The ideal candidate has a strong background in QA leadership within pharmaceutical manufacturing, solid knowledge of GMP, and proven ability to drive quality improvements in a busy production

Qualifikationen

• Bachelor of Science preferably in Chemistry, Pharmacy, Microbiology or Biology, or a bachelor's degree in business administration.
• Eight or more years of experience in quality assurance with at least four years at a supervisory level in QA/manufacturing.
• Experience with pharmaceutical solid and liquid dosage, OTC, and controlled product manufacturing, packaging, audits, compliance, and product disposition.

Aufgaben

• Recruits, evaluates, supervises, applies disciplinary actions, provides recognition, develops and rewards employees under supervision.
• Develops QA Operation's unit goals in alignment with the Quality Unit and site goals.
• Ensures cross training program is in place to maintain workforce flexibility.
• Prepares trainings for new personnel and implements cross-training opportunities.
• Identifies opportunities for new techniques, procedures and evaluates new processes/equipment.
• Reviews and updates area, forms, protocols, and procedures to ensure cGMP compliance.
• Conducts staff meetings to communicate quality, policies, safety, business, and HR information.
• Designs, develops, and presents Quality Assurance project results and plans.
• Prepares and conducts personnel headcount analysis and volume forecast.

Kenntnisse

Quality Assurance

Supervisory experience

cGMP compliance

Documentation & audits

Ausbildung

Bachelor of Science in Chemistry/Pharmacy/Microbiology/Biology

Bachelor's degree in business administration

Jobbeschreibung

Kenvue is seeking a Senior QA Supervisor to lead quality assurance operations at the Las Piedras site. You will oversee QA activities, approve change controls, CAPAs, and product dispositions, and ensure cGMP compliance.

The role involves coordinating with upstream/downstream areas and guiding QA staff. The ideal candidate has a strong background in QA leadership within pharmaceutical manufacturing, solid knowledge of GMP, and proven ability to drive quality improvements in a busy production