QA Manager

POSITION RESPONSIBILITIES

• Manages QA staff and their ability to support cGMP programs, including the review and approval of site-specific batch records, procedures, protocols, calibrations and reports.

• Manages the oversight, review and approval of deviation investigations and change controls pertaining to cGMP production and testing for specific product lines. 

• Ability to draft and implement MBR’s, Process Validations, Equipment Qualification Master Plans (EQMP), and Cleaning Validations.

• Responsible for consistently maintaining safe quality food products by following good manufacturing practices, allergen controls, food defense, HACCP, SQF, and regulatory requirements.

• Ensures visitors, contractors and customers are documented on each visit in and out of the facility to maintain good manufacturing practices, allergen controls, food defense/food security and HACCP controls.

• Responsible for immediately reporting all food safety and quality issues to management.

• Ability to train QA support staff so that they are competent in cGMP policies, procedures, and overall job function

• Responsible for updating and maintaining SOPs so that they fall in-line with CFR Part 111 and CFR Part 211

• Ability to identify problems and areas of opportunity

• Engages and actively communicates with account managers and other departments to ensure that cGMP programs are properly supported.

• Actively communicates with account managers and other departments on the status of projects.

• Represents Eagle Labs Inc during audits from regulatory bodies and clients. 

• Other job duties as required. 

MINIMUM QUALIFICATIONS

Education 

• Bachelor’s degree preferred

Experience

• 2 years cGMP experience in a regulated industry

• 2 years providing quality assurance support preferably to cGMP pharmaceutical or nutraceutical production (other regulated industry)

• 3 years of leadership experience. 

Knowledge, Skills, and Abilities 

• Strong working experience with GMP, FDA, USDA, and SQF standards for food safety

• Must be able to read and understand English job instructions and safety requirements

• Able to lead difficult discussions with customers and subordinates, and find acceptable resolutions

• Ability to use word processing, excel, SAP systems, 

• Knowledge of NSF, CFR Part 111, and CFR Part 211

Certification or License

• HACCP Certification or the ability to obtain certification in the first 6 months

• PCQI Certification or the ability to obtain certification in the first 6 months