Quality Assurance Supervisor

Job Title

Quality Assurance Supervisor

Type of Position Reports to

Full-time Position and reports to QA Director

Scope of Supervision

• Quality Assurance Department Employees
• All staff in relation to cGMP procedures and Records

Department Location

• Quality Assurance 975 Bennett Drive Longwood, FL 32750
• All when pertaining to GMP SOP’s and Training

General Purpose

Assures all product produced at the facility is in cGMP and CFR 21 Part 111 and 117compliance through supervision of Quality Assurance Department personnel. Responsible for the revision of batch records and the release of product. Works with trainer to ensure all training programs and records meet company and cGMP requirements. Works with QA Director and other managers and supervisors to assist and coordinate daily Quality activities throughout the facilities.

POSITION RESPONSIBILITIES
Supervision

• Plan, organize, direct, and monitor the daily activities of all Quality Assurance Personnel.
• Provide guidance and assistance to employees to achieve department requirements and standards.
• Where it pertains to Quality and Regulatory provides mentoring, coordination between QA Director and staff, and opportunities for improvement to Production Management.

Review

• Daily Records, training records, Internal and external audits to ensure compliance of all Regulatory and Quality requirements and best practice. Ongoing to ensure Continual Improvement is being met.

Assist QA Director with Audits
Audit Batch Production Records for accuracy.
Audit laboratory results and maintain all records as required.
Audit of MacroCaps Quality System with QA Director to ensure it meets the GMP and CFR 21 Part 111 requirements
Audit of Facilities for compliance to Quality, Safety and Regulatory requirements

Coordinate External Labs
Keep self well informed with external laboratories to assure all testing is completed in a timely manner.
Interact with other departments to assure quality, production and shipping deadlines are met.

Training
Co-ordinate and Conduct training for staff as needed in areas of Quality, Regulatory, Safety, and other areas as assigned by QA Director.

Communication

Minimum of weekly communication with QA Director, and daily as needed

Keep production (and all relative staff) informed of relevant information to maintain compliance.

Documentation
Maintain Management System to ensure compliance with all Quality and regulatory requirements.
Monitor the overall management system of MacroCap to identify any trends, both negative as well as positive and work with management to take actions as needed in coordination with QA Director.

MINIMUM QUALIFICATIONS

Education
Min. Bachelor’s in relevant field (Biology, Micro-Biology, Chemistry) MS. Preferred.

Experience
Two or more Years Supervisory experience in the pharmaceutical, food, cosmetic, or dietary supplement industry preferably in Quality Assurance.

Knowledge, Skills and Abilities
Knowledge of the FDA Code of Regulations (CFR 21 parts 111 and 117)
Working knowledge of spreadsheet and word processing software.
Working knowledge of cGMP and Safety

Certification or License (Example: CPA, none) : None

The information on this job description is designed to present the major responsibilities and duties necessary to achieve the jobs end results. It is not intended to be comprehensive list of all duties, responsibilities, and qualifications.

End

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Job Type: Full-time

Pay: From $60,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Supervising: 2 years (Preferred)

Ability to Commute:

• Longwood, FL 32750 (Preferred)

Work Location: In person

Salary : $60,000