Director of Quality Assurance

Tampa Bay, FL 33773

Posted: 09/20/2024 Employment Type: Direct Hire Division: Life Sciences Job Number: JN -092024-19651 State: Florida

Job Description

Director of Quality Assurance

Title: Director of Quality Assurance
Location: Largo / Clearwater, FL
Industry: Nutraceutical
Shift: Mon- Fri Day Shift
Salary: 100K and up depending on experience
Employment Type: Direct Placement

Position Overview:
The Director of Quality Assurance is responsible for supporting Production, Facilities, R&D, and Quality with the primary focus of ensuring that products meet strict quality standards throughout the entire supply chain, and for ensuring compliance with certifying bodies/regulatory agency regulations and interpretations.

Primary Responsibilities:
  • Ensure quality system /regulatory requirements are met (e.g. cGMP, CFRs, Food Safety, FSMA, FSVP, etc.)
  • Assist in identifying and implementing quality system enhancements to achieve/maintain third party quality system certification
  • Oversee the management and compliance of the supplier/vendor management program (FDA FSVP); ensuring suppliers and outsourced labs are qualified/re-qualified, as dictated by FDA/FSMA
  • Oversee and improve the Internal Audit program (which may include Mock Recall, Food Defense, Disaster Recovery, Certifying Body Audits), including scheduling, planning, conducting and reporting, close-out and follow-up corrective actions. This includes focus on GMP compliance, and regulatory.
  • Ensure facility is properly permitted / licensed / certified regarding regulatory/3rd party agencies (e.g. US/FL Dept. of Ag., State, Federal, DEA, NSF, etc.)
  • Interface with supplier, customer quality representatives, and regulatory agencies -as required. Prepare and ensure customer readiness / inspections.
  • Assist in the development and implementation of action plans that will ensure progress toward achieving established targets / metrics, quality objectives and business goals.
  • Oversee the Food Safety/Defense Program ensuring the plan is adequate and meets regulatory requirements.
  • Oversee the management of the Training, Pest Control and HACCP/HARPC Programs ensuring regulatory requirements is met Prepare, revise, review and approve, as required, SOPs and related documentation per company change control policies.
  • Actively participate during internal/external audits.
  • Maintain an active role on continuous improvement team.
  • Oversee the management of documents throughout their life cycle.
  • Oversee label compliance activities to ensure all regulations are met.
  • All other duties as assigned.
Willing to work holidays and weekends as needed

Qualifications:
  • Education: Bachelor s Degree, preferably in a Life Sciences related field, or equivalent experience
  • Experience: Minimum of 5 years experience in a cGMP environment (drugs, cosmetics, dietary supplements, or medical device). Minimum of 3 years management or supervisory experience. Internal/external audit experience
  • Other: Knowledge of cGMP, 21 CFR 111, 210, 211, 701, Standard Operating Procedures, and Batch Records. Labeling regulatory experience. Ability to operate Microsoft Office (Outlook, Word, PowerPoint, Excel). Team development and leadership skills. Strong proofreading and writing skills. Work independently as well as in team environments

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

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