Summary of the Position: Develops and deploys the quality system for manufacturing facilities. Must have a good understanding of laboratory practices to ensure systems and procedures comply with government regulations, industry standards, and company policies. Responsible for collaborating with other quality managers and operations management to align material handling, equipment cleaning, and room cleaning with process flows in manufacturing and packaging operations.
Roles and Responsibilities:
1. The SQM must have a thorough understanding of GMP requirements and regulations related to dietary supplements manufacturing and preventive controls for animal food (21 CFR Part 111 and 21 CFR Part 507).
2. Ensure quality processes related to manufacturing and packaging, including all cleaning procedures across facilities.
3. Work closely with operations management to ensure work instructions are appropriate for different work centers.
4. Align batch records with work instructions/OJT and conduct in-process quality checks for all product manufacturing processes (tableting, encapsulation, powders, liquid filling, soft chews, pellets, etc.).
5. Establish standards in relevant areas where necessary.
6. Collaborate with Supply Chain to manage raw material release and availability for manufacturing operations across facilities.
7. Lead internal and external audits related to the microbiology laboratory and develop strategies to address audit findings.
8. Oversee investigations related to manufacturing operations.
9. May act as the Management Representative for Quality when needed.
10. Develop and deploy quality systems (e.g., CAPA, design control, process control) to ensure product conformity.
11. Manage team during regulatory inspections.
12. Ensure quality compliance for contract manufacturers.
13. Communicate effectively within the organization and work well in a team environment.
14. Perform other duties as required to meet company objectives.
Minimum Requirements:
* Strong understanding of quality control testing and assurance processes.
* Knowledge of industry regulations, FDA, USP, AOAC, ICH guidelines; experience with pharmaceutical and nutritional supplement GLP/GMP is preferred.
* Effective interpersonal skills for interaction at all levels.
* Problem-solving skills.
* Motivational and cross-functional team-building skills.
Education and Experience: BS in Chemistry, Microbiology, or related Science field. At least 10 years of experience in quality control and assurance within the nutritional supplement or pharmaceutical industry. Laboratory management experience is required.
Supervisory Responsibilities: Yes – Quality Staff
* Enforce safe work practices and procedures; encourage reporting of hazards.
* Take immediate action to correct unsafe conditions.
* Train employees to identify and report hazards.
* Report incidents promptly and ensure medical treatment and safety measures are in place.
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