A rapidly growing leader of generics/human healthcare products is looking to bring on a QA Manager to help with the current and future growth of the organization.
Summary of the Position: The Sr. Quality Assurance Manager reports to the Senior Quality Management. This person supervises Quality Assurance Generalists, Label Issuance, and Returns. The Quality Assurance Supervisor is responsible for all of the day to day operations, techniques, and activities associated with those departments that are used to fulfill the Quality Assurance requirements of the product and/or service.
Roles and Responsibilities:
- (Bulleted list) Supervising those individuals within the QA department that includes but is not limited to the following responsibilities:
- QAG and Production process monitoring
- Assuring that all GMP requirements and regulations are met through compliance to government regulations, industry standards and Company policies
- Reviewing environmental conditions records and responding to excursions
- Work with Production Supervisors to resolve production problems
- Working with Production, Regulatory Affairs, Marketing, New Product Development and other necessary departments to maintain awareness of Quality Operation activities.
- Product quality and conformance to government regulations, industry standards, and Company policies.
- Developing and deploying the Quality systems (e.g. CAPA, design control, process control) to ensure products conform to defined requirements.
- Understanding and deploying processes to assure conformance to government regulations, industry standards and Company specifications and policies.
- Conducting investigations, assessing and closing deviations, determining impact of the issues that could affect product quality, safety and purity.
- Must be able to effectively communicate with other departments and function within a team environment.
- Must periodically work second and third shift hours in support of personnel on those shifts.
- Performance of other duties as assigned.
Minimum Requirements: Good knowledge of FDA and global regulatory requirements pertaining to manufacturing of nutritional supplement and/or pharmaceutical products. Individual must have good analytical and problem solving skills. Excellent interpersonal/communication/influencing/negotiation skills required. Ability to lead, motivate and cross-functional team building skills.
Education and Experience: BS Degree or BA Degree with a Science major or concentration and/or continuing education credits or certifications in the pharmaceutical industry through a reputable professional society. Minimum of 3 years' experience in Quality in a regulated manufacturing facility (Nutraceutical/Pharmaceutical, Food & Beverage, Chemical, etc.)