Bechtel Recruiting Group
Director of Quality Assurance
Bechtel Recruiting Group, Largo, Florida, United States, 34640
Director of Quality Assurance
Thank you for taking the time to consider applying with the Bechtel Recruiting Group. We commit to fast responses and complete transparency throughout your entire job search. We look forward to working with you.
Job 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.
Essential Functions
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. •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.
Education:•Bachelor's degree, preferably in Engineering or Life Sciences or related field, or equivalent experience.
Experience:•Minimum of 5 years' experience in a cGMP environment (drugs, food, cosmetics, dietary supplements, or medical device)•Minimum of 3 years' management or supervisory experience•Internal/external audit experience
Knowledge, Skills and Abilities:•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•Must have a good interpersonal and communication skill in English, understand both oral and written instructions and be detail oriented.
Thank you for taking the time to consider applying with the Bechtel Recruiting Group. We commit to fast responses and complete transparency throughout your entire job search. We look forward to working with you.
Job 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.
Essential Functions
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. •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.
Education:•Bachelor's degree, preferably in Engineering or Life Sciences or related field, or equivalent experience.
Experience:•Minimum of 5 years' experience in a cGMP environment (drugs, food, cosmetics, dietary supplements, or medical device)•Minimum of 3 years' management or supervisory experience•Internal/external audit experience
Knowledge, Skills and Abilities:•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•Must have a good interpersonal and communication skill in English, understand both oral and written instructions and be detail oriented.