Quality Manager

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. He/She is responsible for working with other quality managers and operations management to align Material handling, equipment cleaning, room cleaning with process flows in manufacturing and packaging operations. 

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

Supervisory Responsibilities:  Yes – Quality Staff

• Enforce Safe Work Practices: It's the supervisor’s responsibility to enforce safe work practices and procedures; failure to do so is an invitation for accidents to occur. 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 or hazards within their authority and ability to do so. When an unsafe or unhealthful workplace condition or hazard cannot be immediately corrected, the supervisor must take temporary precautionary measures. Supervisors must follow-up to ensure that corrective measures are completed in a timely manner to address the hazard.
• Prevent Lingering Unsafe or Unhealthful Workplace Conditions or Hazards: It's the supervisor's responsibility to train and periodically remind employees of what to look for and how to correct or report unsafe conditions or hazards. If a hazard is identified, the supervisor must act to correct.
• Incidents Reporting: Immediately ensure 1st aid is provided by a ERT member and ensure there is no immediate danger to others. Arrange additional medical treatment for the employee if necessary. Provide emergency transportation, if needed. Notify additional rescue/response teams if necessary. 
• Immediately notify EHS for employees seeking medical treatment for work related incidents. Ensure employee completes their sections of the safety incident report. 
• Complete the incident report and email to  Incident Response before the end of your shift. Begin incident investigation Secure the scene. Keep it unchanged to accurately collect the facts. Obtain photos if needed. 
• Coordinate with EHS to form a cross functional team to perform 5 WHY - Root Cause investigation – Other investigation tools may be utilized for more complicated investigations. Corrective action(s) will be agreed upon by the cross functional team based on the root cause. Once the investigation is complete and agreed upon by the cross functional team, email the completed investigation to Incident Reporting