Quality Assurance Supervisor

Job Summary
The Quality Assurance Supervisor is responsible for ensuring timely and effective implementation of company’s policies, procedures, and activities involved in assuring the quality of manufactured products. This individual will collaborate closely with other department managers and supervisory staff to uphold and enhance product quality, address and prevent issues impacting product excellence, optimize productivity, and adhere to regulatory standards.

Key Responsibilities

• Supervise and direct Quality Assurance Technicians/Inspectors tasked with enforcing Good Manufacturing Practices and other quality-related policies to ensure adherence to product quality standards. Top of Form
• Manage the day-to-day Quality Assurance operations, including acting as the primary QA representative for frontline staff.
• Review Production Batch Records and other manufacturing-related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling, and sanitation activities.
• Audit quality control of raw materials, packaging components, labels, and finished products to ensure compliance with established specifications and regulatory standards.
• Collaborate with Engineering, Manufacturing Engineering, Supply chain, and Quality Engineering teams to develop control plans and process validation.
• Create, update, and revise SOPs and Work Instructions for the Quality Unit as well as provide feedback and expertise concerning similar documents to the Production, Sales, and Supply Chain departments.
• Research and assist respective departments to achieve immediate corrective/preventative action response to pertinent customer and internal CAPA's, as required.
• Investigate and document cGMP/process deviations as well as customer complaints and serve on the Material Review Board to disposition non-conforming material.
• Work with Supply Chain to facilitate the return of non conforming materials to suppliers.
• Generate certificates of Compliance and destruction to ensure regulated materials (e.g., hazardous chemicals, OTC product labels) are disposed of according to requirements.
• Develop and maintain QA programs complementary to enterprise quality system, corporate objectives, and policies.

Minimum Qualifications

• Bachelor’s degree in Sciences, quality management, engineering, or related field.
• 5 Years experience in Quality Assurance, preferably in a manufacturing environment.
• Working knowledge of quality management systems.
• Strong understanding of statistical analysis and process improvement methods.
• Growth mindset and willingness to learn and work in a fast paced environment

Skills and Proficiencies:

• Proficient in English language skills: reading, writing, speaking, and comprehension.
• Working knowledge of FDA regulations and GMPs.
• Self-directed with strong organizational skills and attention to detail.
• Proficient in communication, report writing, and grammar.
• Strong aptitude for critical thinking.
• Capable of making confident independent decisions.
• Possesses strong interpersonal and communication abilities, both verbal and written.
• Ability and willingness to train others in the team.

Company Benefits

• Medical, Dental & Vision Insurance
• Flexible Spending Account
• Dependent Care Account
• Paid Time Off (PTO)
• Company Paid Short-Term Disability, Long Term Disability, & Life/AD&D
• 401k contributions
• Summer Flex Time
• Volunteer Time Off
• Bereavement Time Off
• New Parent Paid Leave
• And more!