QA Manager

Eagle Labs; Florida; On-site; USD 90,000 - 130,000; Full time

Job summary

Eagle Labs in Seminole, FL is seeking a QA Manager to oversee cGMP programs, manage QA staff, and ensure regulatory compliance across manufacturing and testing.

You will review batch records, deviations, change controls, validations, and lead audits with regulatory bodies and clients. Strong leadership and communication are essential to train staff and maintain product quality from raw materials to final release.

Qualifications

• 2+ years cGMP experience in a regulated industry
• 2+ years providing quality assurance support preferably to cGMP pharmaceutical or nutraceutical production
• 3 years of leadership experience

Responsibilities

• Manages QA staff and their ability to support cGMP programs, including the review and approval of batch records, procedures, protocols, calibrations and reports
• Oversees deviation investigations and change controls for cGMP production and testing
• Drafts and implements MBRs, Process Validations, EQMP, and Cleaning Validations
• Maintains safe quality products by following GMP, allergen controls, food defense, HACCP, SQF and regulatory requirements
• Represents Eagle Labs Inc during audits by regulatory bodies and clients

Skills

Leadership

cGMP knowledge

Quality Assurance

Regulatory compliance

English language

Tools

SAP

Microsoft Word

Excel

Job description

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QA Manager

Quality Assurance Full Time Seminole, FL, US

2 days ago Requisition ID: 1189

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

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