Overview
Develops and deploys the quality system for manufacturing facilities and must have a good understanding of Laboratory practices to assure systems and procedures are compliant with government regulations, industry standards and Company specifications and policies. Work with quality managers and operations management to align material handling, equipment cleaning, room cleaning with process flows in manufacturing and packaging operations.
Responsibilities
* The SQM 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).
* Ensure quality processes relating to manufacturing and packaging including all cleaning procedures in all facilities.
* Work closely with operations management to ensure work instructions are appropriate for the 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.).
* Establish standards in areas where necessary.
* Work with Supply Chain to manage raw materials release and availability for manufacturing operations in all facilities.
* Lead internal and external audits as they pertain to the Microbiology Laboratory and assist with developing strategies when addressing audit findings.
* Lead or oversee all product or situation investigations relevant to Manufacturing operations.
* May act as the Management Representative for Quality when necessary.
* Develops and deploys the Quality systems (e.g. CAPA, design control, process control) to ensure products conform to defined requirements.
* Manage team for regulatory inspections.
* Manage quality compliance for Contract Manufacturers.
* Communicate effectively with other departments within the organization and function within a team environment.
* Regular attendance is required.
* Perform other assigned duties as may be required in meeting company objectives.
Education and Experience
BS Degree in Chemistry, Microbiology or BA Degree in a related Science field is required. Minimum of 10 years' experience in Quality Control and Assurance in the nutritional supplement and/or pharmaceutical products manufacturing industry. Laboratory management experience is required to be considered for this role.
Senioriry level
* Mid-Senior level
Employment type
* Full-time
Job function
* Other
Industries
* Pharmaceutical Manufacturing
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