Quality Supervisor (Manufacturing)
The following duties are normal for this position. The incumbent may perform some or all of these duties however; it is not an exclusive or all-inclusive list. Other duties may be assigned.
Ensures that all the aspects of the handling, packaging and shipping of finished good products at the site comply with the customer requirements and meet all relevant cGMP regulatory requirements.
Initiates/Creates the following:
- Rework Protocols
- Deviations
- Change Controls
- Validations and Validation Tracker
Reviews and approves the following documents:
- Customer Requirements
- Tools and Techniques
- Job Descriptions for the Quality Department
Provides support to the following personnel:
- Quality Assurance Analyst
- Quality Control Auditor
- In absence of the Sr. Quality Manager, the Quality Supervisor is back-up for all functions mentioned within the Sr. Quality Manager's job description.
Originates or implements improvements to Quality procedures as necessary.
Enters documentation into QMS to allow one central point for documentation.
Supplemental Functions
- Initiates team meetings to address special projects or important changes in customer process; be able to provide meeting minutes and follow up action items.
- Works closely with Production and Quality Management to resolve significant Quality issues in a timely manner which may require real-time and/or follow up activities.
Education & Experience
- Associate's Degree required, Bachelor's degree desired
- Minimum of 2 years combination of training, education and/or experience that provides the required knowledge and abilities to perform the duties listed above
- Bilingual Spanish highly desired
- ASQ or other Quality certification is preferred
Knowledge, Skills & Abilities
- Strong knowledge of FDA regulations, cGMP regulations, and Safety
- Strong knowledge of MS Word and Excel
- Communication, management and technical writing skills
- High degree of problem-solving abilities and is able to independently manage multiple high-level priority projects/workload, ensuring timely completion
- Ability to delegate and direct others
- Good negotiation skills with customer-oriented attitude
- Ability to travel when necessary
Physical Requirements & Work Environment
- Primarily works in a production and/or warehouse setting with time also spent in an office setting
- Frequent walking and standing required
- Occasional travel required
- Occasional lifting up to 25 lbs.
- Must be able to walk, sit, and stand for prolonged periods
