Senior Quality Manager

Roles and 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 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)

· Establish standards in areas where necessary.

· 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.

· Manages team for regulatory inspections...

· Manages 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

Minimum Requirements:

- 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

Job Type: Full-time

Pay: $100,000.00 - $135,000.00 per year

Benefits:

- 401(k)

- 401(k) matching

- Health insurance

- Relocation assistance

- Vision insurance

Work Location: In person