Sr. Quality Assurance Manager
|Lancaster, South Carolina - United States
$85,000.00 - $105,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
We are looking for a Sr. Quality Assurance Manager that 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:
- 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 the 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.
- Good knowledge of FDA and global regulatory requirements pertaining to the manufacturing of nutritional supplement and/or pharmaceutical products.
- Individual must have good analytical and problem-solving skills.
- Excellent interpersonal/communication/influencing/negotiation skills required.
- High-level human relations skills in selecting, developing, and motivating people.
- Excellent motivational and cross-functional team building skills.
- 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 Assurance in the nutritional supplement and/or pharmaceutical products manufacturing industry.
University - Bachelor's Degree/3-4 Year Degree