Guidehouse
Quality Assurance Manager, Sterility Testing
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Quality Assurance Manager, Sterility Testing
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Guidehouse This is a full-time, on-site opportunity based in Bethesda, MD. What You Will Do Provide QA leadership and team management for the laboratory’s Sterility Testing Service to ensure cGMP compliance with FDA regulations. Provide oversight of Quality Management System including document management system, equipment management system, material management system, quality event tracking system, internal and external audit program. Participate in project management for the construction of the new HVAC system. Assist leadership in identifying critical pain points for the cGMP program. Participate in program management of onboarding new global cGMP programs. Review records related to the general operation and upkeep of a GMP Quality Control laboratory. Receive, log, and release incoming supplies and material to the Quality Control laboratory. Support the maintenance of the document control system. Support the maintenance of the Equipment Control and Service program. Support the maintenance of the CAPA, Deviation, Environmental Excursion, Investigations, and Change Control programs. Track, analyze, and report on Quality Performance Indicators (QPIs). Provides QA support and oversight for the resolution of CAPA, Deviations, Environmental Excursions, and Change Control. Act as QA reviewer for investigations, deviations, and CAPA. Participates in Internal Audits to ensure continued adherence to internal procedures and industry best practices. Participate in the GMP training of new employees and contractors. Identify and drive system improvements, both within Quality Assurance and for laboratory operations. Independently develop, write, and lead the implementation of controlled documents. Stay current with changes to current Good Manufacturing Practices. Follow established policies and procedures and apply applicable regulations. Participate in the teaching program of clinical fellows rotating through the Sterility Testing Service. Effectively lead and provide oversight of a team of QA Specialists. What You Will Need Bachelor’s Degree in a science-related discipline. Minimum of SIX (6) years in a laboratory environment. Minimum of TWO (2) years of experience in Quality Assurance or Quality Control. Minimum of TWO (2) years of experience effectively lead and provide oversight of a team of QA Specialists. Strong communications skills, both oral and written. Excellent analytical, organizational and time management skills. Ability to rapidly adapt to changing environment and circumstances. Ability to work effectively in a team environment. Ability to lift 10 – 30 pounds. Excellent hand-eye coordination. Must be able to OBTAIN and MAINTAIN a Federal or DoD PUBLIC TRUST. What Would Be Nice To Have Knowledge of cGMP, aseptic processing, and Microbiology is strongly preferred. The annual salary range for this position is $130,000.00-$216,000.00. What We Offer Medical, Rx, Dental & Vision Insurance. Personal and Family Sick Time & Company Paid Holidays. Parental Leave. 401(k) Retirement Plan. Group Term Life and Travel Assistance. Voluntary Life and AD&D Insurance. Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts. Transit and Parking Commuter Benefits. Short-Term & Long-Term Disability. Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities. Employee Referral Program. Corporate Sponsored Events & Community Outreach. Care.com annual membership. Employee Assistance Program. Supplemental Benefits via Corestream. Position may be eligible for a discretionary variable incentive bonus. About Guidehouse Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.
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Join to apply for the
Quality Assurance Manager, Sterility Testing
role at
Guidehouse This is a full-time, on-site opportunity based in Bethesda, MD. What You Will Do Provide QA leadership and team management for the laboratory’s Sterility Testing Service to ensure cGMP compliance with FDA regulations. Provide oversight of Quality Management System including document management system, equipment management system, material management system, quality event tracking system, internal and external audit program. Participate in project management for the construction of the new HVAC system. Assist leadership in identifying critical pain points for the cGMP program. Participate in program management of onboarding new global cGMP programs. Review records related to the general operation and upkeep of a GMP Quality Control laboratory. Receive, log, and release incoming supplies and material to the Quality Control laboratory. Support the maintenance of the document control system. Support the maintenance of the Equipment Control and Service program. Support the maintenance of the CAPA, Deviation, Environmental Excursion, Investigations, and Change Control programs. Track, analyze, and report on Quality Performance Indicators (QPIs). Provides QA support and oversight for the resolution of CAPA, Deviations, Environmental Excursions, and Change Control. Act as QA reviewer for investigations, deviations, and CAPA. Participates in Internal Audits to ensure continued adherence to internal procedures and industry best practices. Participate in the GMP training of new employees and contractors. Identify and drive system improvements, both within Quality Assurance and for laboratory operations. Independently develop, write, and lead the implementation of controlled documents. Stay current with changes to current Good Manufacturing Practices. Follow established policies and procedures and apply applicable regulations. Participate in the teaching program of clinical fellows rotating through the Sterility Testing Service. Effectively lead and provide oversight of a team of QA Specialists. What You Will Need Bachelor’s Degree in a science-related discipline. Minimum of SIX (6) years in a laboratory environment. Minimum of TWO (2) years of experience in Quality Assurance or Quality Control. Minimum of TWO (2) years of experience effectively lead and provide oversight of a team of QA Specialists. Strong communications skills, both oral and written. Excellent analytical, organizational and time management skills. Ability to rapidly adapt to changing environment and circumstances. Ability to work effectively in a team environment. Ability to lift 10 – 30 pounds. Excellent hand-eye coordination. Must be able to OBTAIN and MAINTAIN a Federal or DoD PUBLIC TRUST. What Would Be Nice To Have Knowledge of cGMP, aseptic processing, and Microbiology is strongly preferred. The annual salary range for this position is $130,000.00-$216,000.00. What We Offer Medical, Rx, Dental & Vision Insurance. Personal and Family Sick Time & Company Paid Holidays. Parental Leave. 401(k) Retirement Plan. Group Term Life and Travel Assistance. Voluntary Life and AD&D Insurance. Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts. Transit and Parking Commuter Benefits. Short-Term & Long-Term Disability. Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities. Employee Referral Program. Corporate Sponsored Events & Community Outreach. Care.com annual membership. Employee Assistance Program. Supplemental Benefits via Corestream. Position may be eligible for a discretionary variable incentive bonus. About Guidehouse Guidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.
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