Quality Supervisor

Position: Quality Supervisor Department: Quality Report To: Sr. Director of Quality Revision: 07/02/2025 ☒ Exempt ☐ Non-exempt

Primary Purpose:

Provides leadership and guidance for Quality Technicians and Sanitation Technicians in their job responsibilities, Inspects Quality logs and forms, reviews blending and production batch records, issues corrective actions, coaches, mentors, trains, and ensures compliance with policies and procedures.

Scope:

• Overall responsibility to provide leadership and act as backup role for Quality leadership (manager/director).
• This role will provide working leadership as an intermediary for quality techs, document control, and quality leadership.
• Act as the main responsible individual for all testing, review, and release of materials
• Act as main contact for all outside laboratory questions, tracking, and follow up
• Acts as main internal source of communication for all products/material issues that could affect production schedule.

Job Duties & Responsibilities:

• Monitor QC Tech job duties and responsibilities.
• Review Batch Production Record for documentation accuracy and completion.
• Train QC techs and acts as a back-up when they are absent to ensure that the following duties are covered.
• Sampling, sample retentions, sample submission for testing
• QC blending line clearance
• QC blending batch record review and completion
• QC packaging line clearance and first article inspections
• QC hold and release
• QC packaging batch record review and completion
• Sample processing and result interpretation
• Product fulfilment according to specification
• Disposition for minor non-conformances
• Coordinate environmental monitoring and hygiene.
• Supports the creation, implementation, and continuous review of quality management systems (Deviation, Rework, OOS, NCR, RCA/CAPA)
• Alongside other departments Develop, Review, and Approve specifications for all stages of manufacturing to continuously assure compliance with 21 CFR 101, 111, 117.
• Supports Document Control in review, release, and final approval of controlled document as part of an over document control process.
• Translate third party laboratory results, in-house testing, and any supplemental information into a Biovation COA for product approval/release for use and shipment.
• Assist in audits and regulatory document requests.
• Enforce compliance with cGMP, GDP and handwashing policies throughout the facility.
• Assist in investigations to resolve product and process issues related to quality and compliance.
• Other Duties as assigned.
• Assist Manager and Director of Quality as needed.
• Performs audits on all SOPs to make sure all procedures are up to date. Due to performing these audits, training, and completing quizzes on the SOPs is not required.

Required Qualifications:

• High School diploma, GED or equivalent experience.
• Proficiently read, speak and write English in order to meet FDA requirements for record keeping and packaging purposes.
• Perform basic mathematical calculations-add, subtract, multiply, divide, percentages.
• Preventative Control Qualified Individual (PCQI) preferred.
• Regulatory and Certification Audit Experience (NSF, SQF, FDA, Customer) strongly preferred.
• 1-2 years of Quality Assurance/Quality Control experience in a Food/Dietary Supplements Manufacturing environment or similar experience.
• Experience with Encapsulation and Coating preferred.
• May be required to work some holidays/weekends.
• Must be able to communicate clearly and effectively, both in writing and verbally.
• Must be able to follow detailed instructions accurately.
• Familiarity with FDA Regulations, GMPs HACCP, and SOPs.

Note: Employees may be crossed trained in any or all areas. At any point in time an employee may be asked by the manager to perform responsibilities outside the areas indicated above. The SOPs necessary to perform the above responsibilities are listed on the Personal Training Record developed for this position.