GENERAL PURPOSE
Quality Assurance (QA) Manager’s primary duty is to maintain appropriate oversight of cGMP processes to ensure the quality of produced pharmaceutical and nutraceutical products. Responsibilities include managing and monitoring quality assurance personnel systems, providing oversight for processes and facilities to ensure regulatory compliance in the manufacture of pharmaceutical and nutraceutical products, ensuring comprehensive technical and administrative review of the batch and analytical data generated by manufacturing and cGMP test laboratories relating to raw material, in-process and product release, managing and monitoring final batch disposition of manufactured products and participating in investigations and corrective action identification and implementation process for deviations, change controls, and non-conformances. Additionally, oversight in establishing process validation and the implementation of IQ/OQ is expected.
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
Skills Required
- Bachelor's degree
- 2 years of cGMP experience in a regulated industry
- 2 years of quality assurance support experience, preferably in cGMP pharmaceutical or nutraceutical production
- 3 years of leadership experience
- Working experience with GMP, FDA, USDA, and SQF standards for food safety
- Ability to read and understand English job instructions and safety requirements
- Ability to lead difficult discussions and resolve issues with customers and subordinates
- Ability to use word processing software, Excel, and SAP systems
- Knowledge of NSF, CFR Part 111, and CFR Part 211
- HACCP Certification or ability to obtain certification within the first six months
- PCQI Certification or ability to obtain certification within the first six months
What We Do
Eagle Labs, Inc. is a U.S.-based full-service contract manufacturer serving brands in the nutritional-supplement and skin-care markets. It makes capsules, tablets, liquids, gummies and skin-care products in the United States, and provides turnkey support for customers. The company emphasizes quality, rigorous product testing, transparent service and innovation, with vertically integrated capabilities intended to help customer brands succeed in the marketplace.
