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Manufacturing Quality Systems Leader
3 weeks ago
Manufacturing Quality Assurance Specialist
Job Description Develops and deploys quality systems for manufacturing facilities. Requires a good understanding of laboratory practices to ensure compliance with government regulations, industry standards, and company specifications and policies. Collaborates with quality managers and operations management to align material handling, equipment cleaning, and room cleaning with process flows in manufacturing and packaging operations.Responsibilities
- Must have a very good understanding of GMP requirements and regulations relating to dietary supplements manufacturing and preventive controls for animal food (21 CFR Part 111 and 21 CFR Part 507).
- Ensures quality processes relating to manufacturing and packaging, including all cleaning procedures in all facilities.
- Works closely with operations management to ensure work instructions are appropriate for different work centers.
- Responsible for aligning batch records with work instructions/OJT as well as in-process quality checks in all product manufacturing (tableting, encapsulation, powders, liquid filling, soft chews, pellets, etc.).
- Establishes standards in areas where necessary.
- Works with supply chain to manage raw materials release and availability for manufacturing operations in all facilities.
- Leads internal and external audits as they pertain to the microbiology laboratory and assists with developing strategies when addressing audit findings.
- Leads or oversees all product or situation investigations relevant to manufacturing operations.
- May act as the management representative for quality when necessary.
- Develops and deploys quality systems (e.g., CAPA, design control, process control) to ensure products conform to defined requirements.
- Manages team for regulatory inspections.
- Manages quality compliance for contract manufacturers.
- Communicates effectively with other departments within the organization and functions within a team environment.
- Regular attendance is required.
- Performs other assigned duties as may be required in meeting company objectives.
BS degree in chemistry, microbiology, or BA degree in a related science field is required. A minimum of 10 years' experience in quality control and assurance in the nutritional supplement and/or pharmaceutical products manufacturing industry is required. Laboratory management experience is necessary to be considered for this role.
Seniority level- Mid-senior level
- Full-time
- Other
- Pharmaceutical manufacturing
