Overview
Summary of the Position: Develops and deploys the quality system for manufacturing facilities and must have a good understanding of laboratories practices to assure systems and procedures are compliant with government regulations, industry standards and company specifications and policies. Works with 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
* 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 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.
* 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.
* 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.
Supervisory Responsibilities
* Yes – Quality Staff
* Enforce Safe Work Practices: It is the supervisor’s responsibility to enforce safe work practices and procedures; workers must be encouraged to identify unsafe or unhealthful workplace conditions or hazards.
* Correct Unsafe Conditions: Supervisors must take immediate steps to correct unsafe or unhealthful workplace conditions; if not immediately correctable, take temporary precautions and follow up to ensure corrective measures are completed.
* Prevent Lingering Unsafe Conditions: Train and remind employees what to look for and how to correct or report hazards; act to correct hazards identified.
* Incidents Reporting: Immediately ensure first aid is provided and there is no danger to others; provide emergency procedures and notify necessary teams.
* Incident Reporting: Notify EHS, complete the incident report, and email to Incident Response by end of shift. Begin investigation and preserve the scene; obtain photos if needed.
* Root Cause Investigation: Coordinate with EHS to perform 5 WHY and other investigations; determine corrective actions and share final investigation with Incident Reporting.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Manufacturing
* Pharmaceutical Manufacturing
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