Job Summary: The Quality Control Manager is responsible for ensuring compliance with quality standards and regulatory requirements in a cGMP environment. This role involves reviewing production batch records, auditing quality control processes, and implementing policies and procedures to maintain product quality standards.
Key Responsibilities:- 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.
- Review, revise, and create Standard Operating Procedures (SOPs) as needed.
- Assist in the implementation of policies, operating procedures, quality systems, and programs that ensure proper testing, evaluation, inspection, and technical support to meet product quality standards.
- Act as QA reviewer for investigations, deviations, complaints, and CAPAs as designated by QA Management.
Required Qualifications:- At least one year of Quality Assurance experience in a cGMP environment.
- Bachelor's degree in Life Science or equivalent.
- Good knowledge of current Good Manufacturing Practices, preferably 21 CFR Part 111, 211, IPEC, ICH Q7, FSSC 2200, and food safety.
- Basic understanding of chemical and microbiological analysis and math skills.
- Ability to work in a fast-paced environment, meet deadlines (overtime work required), and make effective decisions.
- Skilled in organization and prioritization, with strong attention to detail.
- SAP experience is preferable.
Preferred Qualifications:- Additional certifications in Quality Assurance or related fields.
- Experience in a supervisory role within a quality control environment.
- Familiarity with industry standards and regulations relevant to the specific products handled.
- Advanced knowledge of statistical process control (SPC) and quality improvement methodologies.
Education: Bachelors Degree
Certification: Quality Assurance