· 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 21CFR Part 507)
· Ensures 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 record with work instructions/OJT as well as in-process Quality checks in all product manufacturing (Tableting, Encapsulation, Powders, liquid filling, soft chews, pellets etc)
· The SQM will work very closely 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.
· Communicate effectively with other departments within the organization and function within a team environment.
· Perform other assigned duties as may be required in meeting company objectives
- A strong understanding of Quality Control testing and Quality Assurance processes.
- Thorough working knowledge of industry regulations, FDA, USP, AOAC, and ICH guidelines; experience implementing and maintaining adherence to pharmaceutical and/or nutritional supplement GLP/GMP is strongly desired.
- Effective interpersonal skills and the ability to interact with all levels of personnel are required.
- Demonstrated problem-solving skills.
- Excellent motivational and cross-functional team building skills.
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
- 401(k)
- 401(k) matching
- Health insurance
- Relocation assistance
- Vision insurance
- Rock Hill, SC 29730: Relocate before starting work (Preferred)