Summary of the Position: Develops and deploys the quality system for manufacturing facilities and must have a good understanding of laboratory practices to ensure systems and procedures comply with government regulations, industry standards, and company policies. Responsible for working with other quality managers and operations management to align material handling, equipment cleaning, and room cleaning with process flows in manufacturing and packaging operations within Nutramax and CMOs.
Roles and Responsibilities:
1. The SQM must have a strong 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 in manufacturing processes such as tableting, encapsulation, powders, liquid filling, soft chews, and pellets.
5. Establish standards where necessary.
6. Collaborate with Supply Chain to manage raw materials release and availability for manufacturing.
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. 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 conformance.
11. Manage teams for regulatory inspections.
12. Ensure quality compliance for contract manufacturers.
13. Communicate effectively across departments and work within a team environment.
14. Maintain regular attendance.
15. Perform other duties as required to meet company objectives.
Minimum Requirements:
* Strong understanding of quality control testing and assurance processes.
* Thorough knowledge of industry regulations, FDA, USP, AOAC, and ICH guidelines; experience with pharmaceutical and nutritional supplement GLP/GMP compliance is preferred.
* Effective interpersonal skills for interaction at all levels.
* Proven problem-solving skills.
* Excellent 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 – overseeing quality staff.
* Enforce safe work practices and procedures.
* Correct unsafe conditions promptly.
* Train employees to identify and report hazards.
* Report incidents immediately, ensure first aid, and coordinate investigations.
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