Current jobs related to Associate Director, Quality Assurance - Germantown - Precigen, Inc
-
Quality Assurance Director
2 weeks ago
Germantown, Maryland, United States uBriGene Biosciences Full timeJob Title: QA DirectorAt uBriGene Biosciences, we are seeking a highly skilled and experienced QA Director to lead our quality assurance program.Job Summary:The QA Director will be responsible for overseeing and coordinating our QA program, ensuring compliance with regulatory requirements, and promoting a culture of quality within the organization.Key...
-
Associate Director, Quality Assurance
3 weeks ago
Germantown, Maryland, United States Precigen, Inc Full timeJob OverviewPrecigen, Inc. is a biopharmaceutical company dedicated to advancing gene and cell therapies using precision technology. We are seeking a highly motivated and skilled Associate Director, Quality Assurance, to lead the development, implementation, and execution of Quality Systems for our organization.The successful candidate will manage GxP...
-
Senior Quality Assurance Director
3 weeks ago
Germantown, Maryland, United States Precigen Full timePrecigen is a pioneering biopharmaceutical company at the forefront of gene and cell therapies. We leverage precision technology to target complex diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.Our innovative approach to cell and gene therapies has led to the development of novel manufacturing...
-
Quality Assurance Specialist
2 weeks ago
Germantown, Maryland, United States Hughes Full timeJob SummaryHughes is seeking a highly skilled Quality Assurance Specialist to join our team in the Hughes Network Systems division. As a key member of our quality team, you will be responsible for ensuring the highest quality standards are met in the development and production of our satellite communication solutions.Key ResponsibilitiesWork with suppliers...
-
Deputy Quality Assurance Manager
6 months ago
Germantown, United States Tetra Tech Full timeTetra Tech is looking for a Deputy Quality Control Manager (remote/hybrid) that supports the Operating Unit (OU) Quality Assurance Manager in all aspects of corporate and programmatic QA/QC functions. Includes auditing and reporting; developing, reviewing, and maintaining QA/QC tools; and developing and presenting training materials relevant to the OU main...
-
Quality Assurance Specialist
3 weeks ago
Germantown, Maryland, United States SES Government Solutions Full timeJob SummaryAs a Quality Assurance Specialist at SES Government Solutions, you will be responsible for developing and implementing quality systems to ensure the delivery of high-quality products and services. This role requires a strong understanding of quality principles and practices, as well as excellent communication and problem-solving skills.Key...
-
Quality Assurance Manager
4 weeks ago
Germantown, Maryland, United States Precigen Full timeJob Title: Quality Assurance ManagerPrecigen is seeking a detail-oriented and skilled Quality Assurance Manager to work with our QA Compliance team.Job Summary:The Quality Assurance Manager will primarily manage/support Precigen's Vendor and Raw Materials Management programs. This role will ensure compliance with applicable regulations and company...
-
Quality Assurance Manager
1 day ago
Germantown, United States Integration International Inc. Full timeJob Details: Title: Quality Assurance (QA) ManagerLocation: Germantown, WI 53022 - OnsiteDuration: 03 Months (Temp to perm possible conversion)Pay rate: $45-55/hr. on W2. Note: THIS IS NOT IT ROLEPosition: Senior Quality Manager, overseeing quality function across 3 plantsResponsibilities:Manage the quality function for 3 plants that manufacture cultures,...
-
Quality Assurance Manager
20 hours ago
Germantown, United States Integration International Inc. Full timeJob Details: Title: Quality Assurance (QA) ManagerLocation: Germantown, WI 53022 - OnsiteDuration: 03 Months (Temp to perm possible conversion)Pay rate: $45-55/hr. on W2. Note: THIS IS NOT IT ROLEPosition: Senior Quality Manager, overseeing quality function across 3 plantsResponsibilities:Manage the quality function for 3 plants that manufacture cultures,...
-
Quality Assurance Specialist
3 weeks ago
Germantown, Wisconsin, United States MGS Mfg. Group, Inc Full timeJob DescriptionMGS Mfg. Group, Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring product compliance to internal and customer specifications, as well as compliance to MGS processes.The ideal candidate will have a strong background in quality management...
-
Senior Quality Assurance Specialist
4 weeks ago
Germantown, Maryland, United States Actalent Full timeJob SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Actalent. The successful candidate will be responsible for ensuring the quality and integrity of our services, while maintaining compliance with regulatory requirements.Key ResponsibilitiesDevelop and implement quality assurance policies and proceduresConduct...
-
Quality Assurance Specialist
3 weeks ago
Germantown, Maryland, United States Manpower Group Inc. Full timeJob Summary:We are seeking a highly motivated and detail-oriented Quality Assurance Technician to join our team at Manpower Group Inc. in Menomonee Falls, WI. As a Quality Assurance Technician, you will be responsible for ensuring the quality and safety of our food products.Key Responsibilities: Conduct food safety and quality control audits to ensure...
-
Quality Assurance Specialist
3 weeks ago
Germantown, Maryland, United States Hughes Full timeJob Summary:Hughes is seeking a Quality Assurance Specialist to join our team in Germantown, MD. This role will be responsible for working with suppliers related to electrical components, including SMT & PCBA manufacturing experience and background.Responsibilities:Work with suppliers to ensure quality standards are metDocument and communicate issues using...
-
Quality Assurance Specialist
3 weeks ago
Germantown, Maryland, United States Leonardo DRS Full timeJob SummaryLeonardo DRS is seeking a highly skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality engineering and a proven track record of delivering high-quality results.Key Responsibilities* Develop and implement quality plans and procedures to ensure compliance with regulatory requirements and...
-
Quality Assurance Technician
4 weeks ago
Germantown, United States Manpower Full timeQuality Assurance Technician- $26-$29/hr. 8am to 4:430pm Our client in Germantown, Wi. is looking for hardworking, motivated talent to join their team Quality team. Don’t wait… apply today! What's in it for you? $26-$29/hr. 1st Shift 8am to 4:30pm Paid training Full time hours Clean and safe work environment Temp to hire Create food...
-
Quality Assurance Technician
4 weeks ago
Germantown, United States Manpower Full timeQuality Assurance Technician- $26-$29/hr. Menomonee Falls, WI 8am to 4:430pm Our client in Menomonee Falls, Wi. is looking for hardworking, motivated talent to join their team Quality team. Don’t wait… apply today! What's in it for you? $26-$29/hr. 1st Shift 8am to 4:30pm Paid training Full time hours Clean and safe work environment Temp...
-
Quality Assurance Manager
2 weeks ago
Germantown, Maryland, United States Precigen, Inc Full timeJob SummaryPrecigen, Inc. is seeking a detail-oriented and skilled Quality Assurance Manager to work with our QA Compliance team. This role will primarily manage/support Precigen's Vendor and Raw Materials Management programs. The position works to ensure compliance with applicable regulations and company procedures/policies.This is an onsite role in our...
-
Quality Assurance Technician
2 weeks ago
Germantown, United States Manpower Full timeJob DescriptionJob DescriptionQuality Assurance Technician- $26-$29/hr.8am to 4:430pmOur client in Germantown, Wi. is looking for hardworking, motivated talent to join their team Quality team. Don’t wait… apply today!What's in it for you?$26-$29/hr. 1st Shift 8am to 4:30pmPaid trainingFull time hoursClean and safe work environmentTemp to...
-
Quality Assurance Specialist
3 weeks ago
Germantown, Maryland, United States Leonardo DRS Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Leonardo DRS. The successful candidate will be responsible for developing and implementing quality systems, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives.Key ResponsibilitiesDevelop and maintain quality plans,...
-
Senior Quality Assurance Manager
4 days ago
Germantown, WI, United States Indotronix Avani Group Full timeJob Title: Senior Quality ManagerLocation: Germantown, WIDuration: 6+ months Pay rate: $55/hr. on W2Job Description:Responsible for assurance that all Cultures, Enzymes, mixes and Media final product shipments meet or exceed customer requirements. Come be part of our growth journey!Your key responsibilities:Manage the quality function for 3 plants that...
Associate Director, Quality Assurance
2 months ago
Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.
Precigen has developed novel manufacturing processes to deliver UltraCAR-T® and AdenoVerse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies, and are working toward FDA approval and commercialization of our gene therapy treatment for Recurrent Respiratory Papillomatosis (RRP).
Precigen is seeking a highly motivated and skilled Associate Director, Quality Assurance, to work with our Quality Assurance (QA) team. This role will lead the development, implementation and execution of Quality Systems for Precigen while managing GxP Compliance activities for Precigen. The incumbent works closely with personnel and leaders in product development functional areas to ensure compliance with applicable regulations, industry standards as well as regulatory requirements and commitments.
DUTIES AND RESPONSIBILITES:
- Prepare the site for regulatory inspection through principles of quality risk management.
- Responsible for management of the site self-inspection program (develop internal audit plans, lead and participate in audit program, etc.).
- Manage inspections by FDA or other regulatory bodies; develop and improve systems for servicing inspections.
- Facilitate and contribute to transition of Precigen Quality System to commercial readiness.
- Ensure compliance with all regulations, requirements and industry standards.
- General “Champion” for Quality within Precigen.
- Contribute to the reporting of Quality metrics for performance of the Quality System and GxP compliance.
- Assist in the authorship, review and/or approval of company policies, procedures, SOPs, and work instruction documents as they relate to GxP.
EDUCATION AND EXPERIENCE:
- Bachelor’s degree in Life Sciences or related field;
- Ten (10)+ years of QA experience in the pharmaceutical or biotech industry
- Experience in development and implementation of commercial Quality Systems is preferred.
- Strong knowledge of global regulatory and compliance standards.
- Experience in Quality aspects of preparation efforts for product development.
- Experience and success in leading a company through pre-approval and post-approval Regulatory inspections is preferred.
- Knowledge and experience in application of Risk Management principles.
DESIRED KEY COMPETENCIES:
- Exceptional leadership, planning, organization, and execution skills.
- Ability to understand and execute the company’s mission and values.
- Strong analytical and decision-making skills with attention to detail and quality.
- Exhibits impeccable confidentiality on sensitive, supporting tasks.
- Ability to anticipate and solve problems while analyzing complex issues and environments.
- Ability to communicate and work effectively and collaboratively with all levels of employees in various communication mediums.
- Possess a high degree of personal responsibility.
- Ability to adapt and succeed in a milestone-driven, rapidly changing product development and commercialization environment.
- Ability to prioritize and re-prioritize activities as needed to accomplish unanticipated requests or initiate new projects requiring immediate attention.
- Demonstrates the highest ethical standards and trustworthiness.
- Strong verbal and written communication and interpersonal skills.
EOE MFDV
