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.
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