QA Manager

Engramec; Town of Florida (NY); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company based in New York is seeking a Quality Assurance (QA) Manager to maintain oversight of cGMP processes. The role includes managing QA staff, ensuring compliance with regulatory standards, and conducting investigations into quality deviations. Candidates should have at least 2 years of cGMP experience and 3 years in a leadership role. Strong communication skills and the ability to lead challenging discussions are essential. HACCP and PCQI certifications are required to be obtained within the first 6 months.

Qualifications

• 2 years of cGMP experience in a regulated industry.
• 3 years of leadership experience.
• HACCP and PCQI certifications or the ability to obtain them.

Responsibilities

• Manage QA staff and support cGMP programs.
• Oversee deviation investigations and change controls.
• Draft and implement MBRs and process validations.

Skills

GMP knowledge

Leadership

Problem identification

Communication skills

Tools

Microsoft Word

Microsoft Excel

SAP systems

Job description

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