Sr. QA Specialist
Sr. QA Specialist ($95K-$105K/year) This company is a pioneer in the cGMP production sector and is committed to developing gene therapy. Their goal is to create novel, secure, and efficient long-term treatments for illnesses by utilizing their expertise, resources, technology, and knowledge in the fields of translational and regulatory science. As they work to make a difference with every product and instill hope in the hearts of every patient and their family, there is no condition too uncommon or difficulty too great. The main idea of this biotech company is the full-service production of Adeno Associated Viruses (AAV). Every year, they collaborate with more than 100 clients to produce AAV at levels of development, toxicological, clinical, and commercial grade. Duties and Responsibilities: Scheduling, preparing, and performing internal and external audits support of GMP Assembling and coordinating the activities of the audit team, if needed. Performing audits in accordance with the company's standard operating procedures, quality policies, GMP regulations. Escalating compliance issues, as needed. Communicating audit results to management and auditees through written audit reports. Leading post-audit activities, following up on vital corrective and preventive actions by resolving any issues. Assisting with hosting facility inspections by acting as ascribe and/or document reviewer, as needed. Drafting and issuing periodic reports to site management, as requested. Assignment, tracking and completion of CAPA activities associated with audits. Assisting with training/orientation for new Quality Auditing staff. Knowledge, Skills, and Abilities Required BA with at least three years of related experience in Biotech/Pharmaceutical industry At least three years of audit experience in a GMP environment preferred. Detailed oriented; ability to track timelines and milestones. Negotiation skills and ability to communicate with all levels of an organization. Proficiency in developing and writing procedures, audit reports and corrective action plans. Experience in using Track wise is preferred. Ability to work with minimal supervision.
US$95000 - US$105000 per year
Columbus
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Quality Director
Director of Quality - Pharmaceuticals Working Situation: Onsite Level: Director/ Executive Our Client is seeking a highly motivated and experienced Director of Quality to join their growing team. As the Director of Quality, you will play a pivotal role in ensuring the quality and compliance of our pharmaceutical products. You will lead our Quality team, oversee responsibilities for all activities associated with cGMP compliance including incoming quality, laboratories, documentation, training, auditing, manufacturing quality, and validation oversight The Director of Quality will: Provide strategic leadership to the Quality team, setting clear goals and expectations, and fostering a culture of excellence and continuous improvement. Plan and conduct internal and external quality audits to ensure compliance with regulatory standards and identify areas for improvement. Responsible for the management of all aspects of the site cGMP documentation system. Ensure compliance with all relevant regulatory requirements, including FDA and other global regulatory agencies, and oversee the preparation and execution of regulatory inspections. Establish and maintain effective quality systems, including SOPs, document control, change control, and CAPA programs. Key role in the technical transfer of analytical methods and specifications for new products from R&D to Operations/QA. The Director of Quality has the following Qualifications: Bachelor's Degree in Biology, Chemistry, Engineering, or related life sciences fields. Minimum of 12 years of experience in the pharmaceutical industry with at least 8 years in a leadership position. Ideally has Aseptic solution experience/exposure In-depth knowledge of FDA and international regulatory requirements and quality standards. Strong problem-solving and analytical skills, with a track record of implementing effective quality improvement initiatives. If you are interested in the role of Director of Quality, don't hesitate to apply today!
US$180000 - US$205000 per annum
Tampa
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Quality Assurance Supervisor
The position of QA will join a dynamic and global leading company in the medical device space, which includes two strong global brands in the space of Ostomy; Continence Care; and Critical Care. Striving for a dynamic Culture of Quality to continuously improve product production. Responsibilities: Oversee the QA department and staff as far as development, training and onboarding. Develop and maintain strategies for the QA function and communicating with key. stakeholders. Develop and implement the QMS. Implementation of internal and external Audits. Oversee complaints, risk management, notified bodies and change control. Oversee the introduction of new products, changes to existing products and innovation. Support the QA operating budget in conjunction with the facility manager. Oversee finished goods product release, including returns handling. Decision making authority in relation to product quality in conjunction with stakeholders. Requirements: Bachelor degree in Quality/Science or Engineering 5+ years experience in Medical device/Pharma industry in Quality positions including Quality system leadership. Experience with ISO13485, 14971, FDA, MMD/MMR Demonstrated knowledge of problem solving and implementing continuous improvement Demonstrated ability to manage/lead a team. Excellent communication skills, written and verbal Fluent English
Negotiable
Netherlands
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Quality Systems Engineer
Summary: As the Quality Systems Engineer, you will ensure the implementation, maintenance, monitoring, and reporting of designated quality system processes to ensure their sufficiency and continual enhancement in an ISO13485 environment. With a primary focus on nonconformance and Corrective and Preventive Action (CAPA) quality systems, this role spearheads and assists in investigations, root cause analyses, corrective actions, and the management of nonconformance and CAPA processes. The ideal candidate possesses a robust background in quality systems, adept problem-solving abilities, and a steadfast commitment to upholding quality standards within the medical device industry. Key Responsibilities: Standardize process and reporting protocols to accurately document nonconformances, CAPAs, and associated corrective actions in compliance with regulatory directives within the medical device industry. Supervise, gather, and analyze quality data, and furnish reports on external and internal audit observations and the status of corrective actions. Collaborate with assigned business lines to conduct inquiries into product quality issues, deviations, out-of-specification occurrences, and nonconformances, ensuring swift and effective resolutions. Develop training materials and resources to enable staff to employ root cause analysis methodologies (such as 6M, Fishbone, 5 Whys, etc.) to identify underlying factors contributing to nonconformances. Create and execute CAPAs to address identified root causes and prevent the recurrence of nonconformances, ensuring clear definition, timely execution, and effective tracking to completion. Compile and deliver reports summarizing investigation findings, root causes, corrective actions, and outcomes to management and relevant stakeholders. Collaborate with cross-functional teams, including Quality, Regulatory, Operations, R&D, etc., to implement process enhancements based on analyses from nonconformance investigations. Monitor the efficacy of implemented corrective actions, utilizing key performance indicators to assess progress and drive continual improvement. Stay abreast of pertinent quality standards, regulatory requirements, and industry best practices related to nonconformance and CAPA processes. Responsible for overseeing and reporting on quality data in other designated quality system processes, as assigned. Qualifications: Education and Experience: Bachelor's Degree in Life Sciences or a related technical discipline (e.g., biomedical engineering) or field. Minimum of 5 years of experience in an ISO 13485 environment. At least 3 years of direct experience in nonconformance and CAPA investigation within the medical device industry. Previous experience supporting and facilitating internal and external audits within the medical device field. Certificates, Licenses, Registrations: Certification as a quality auditor or similar industry certification. Benefits: Full-time team members become eligible for benefits starting the first day of the month following 30 days of employment. These include: Health Insurance: High Deductible Health Plan (HDHP) with Health Savings Account (HSA) - with an employer contribution of $1,040 annually. High Preferred Provider Organization (PPO) Low Preferred Provider Organization (PPO) Flexible Spending Account (FSA) Dental Insurance Vision Insurance Basic Life Insurance (Employer-paid) Supplemental Life Insurance Short-term Disability Insurance (Employer-paid) Long-term Disability Insurance 401(k) Plan with a 4% Employer Match Paid Time Off (accrued at 120 hours per year)* 9 Paid Holidays Access to Continuing Education and Seminar Programs Employee Assistance Program (EAP) Fitness Room Access
US$100000 - US$110000 per year
Minneapolis
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Senior Quality Assurance Manager
Senior Quality Assurance Manager Location: Atlanta, GA Working Situation: Remote Level: Senior Level We are currently seeking a talented and experienced Senior Quality Assurance Manager to join our team in Atlanta, GA. We are a global biotechnology company focusing on human and animal tissues, cell products, and other biofluids. This permanent position offers an exciting opportunity for a Quality Assurance professional with expertise in Good Clinical Practice (GCP), Good Manufacturing Practice (GMP/cGMP) and auditing. As the Senior Quality Assurance Manager, you will be responsible for ensuring compliance with GCP, GMP and maintaining a Quality culture while developing and implementing training programs, conducting audits and inspections, compiling detailed reports, and supervising staff. The Senior Quality Assurance Manager will: Lead GCP/GMP trainings, ensure compliance, and update relevant parties Compile audit findings, review responses, and follow up Review System Validation protocols and maintain QA records Develop QA auditing procedures and SOPs, manage scheduling Serve as liaison for client and regulatory inspections, communicate with stakeholders Conduct internal and external audits, and ensure policy adherence for all regulatory bodies Supervise staff, including training, assigning work, conducting appraisals, and providing feedback The Senior Quality Assurance Manager will have the following qualifications: Bachelor's Degree in relevant field, Biology or Chemistry preferred 9+ years of relevant industry experience 4+ years leading a team ASQ certification, preferred If you're interested in joining our team as the Senior Quality Assurance Manager, apply now!
US$150000 - US$180000 per annum
Atlanta
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Sr. QA Specialist
Sr. QA Specialist Position ($95K-$105K/year) This company is a pioneer in the cGMP production sector and is committed to developing gene therapy. Their goal is to create novel, secure, and efficient long-term treatments for illnesses by utilizing their expertise, resources, technology, and knowledge in the fields of translational and regulatory science. As they work to make a difference with every product and instill hope in the hearts of every patient and their family, there is no condition too uncommon or difficulty too great. The main idea of this biotech company is the full-service production of Adeno Associated Viruses (AAV). Every year, they collaborate with more than 100 clients to produce AAV at levels of development, toxicological, clinical, and commercial grade. Duties and Responsibilities: Scheduling, preparing, and performing internal and external audits support of GMP Assembling and coordinating the activities of the audit team, if needed. Performing audits in accordance with the company's standard operating procedures, quality policies, GMP regulations. Escalating compliance issues, as needed. Communicating audit results to management and auditees through written audit reports. Leading post-audit activities, following up on vital corrective and preventive actions by resolving any issues. Assisting with hosting facility inspections by acting as ascribe and/or document reviewer, as needed. Drafting and issuing periodic reports to site management, as requested. Assignment, tracking and completion of CAPA activities associated with audits. Assisting with training/orientation for new Quality Auditing staff. Knowledge, Skills, and Abilities Required BA with at least three years of related experience in Biotech/Pharmaceutical industry At least three years of audit experience in a GMP environment preferred. Detailed oriented; ability to track timelines and milestones. Negotiation skills and ability to communicate with all levels of an organization. Proficiency in developing and writing procedures, audit reports and corrective action plans. Experience in using Track wise is preferred. Ability to work with minimal supervision.
US$95000 - US$105000 per year
Columbus
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Senior Quality Control Chemist
Senior Quality Control Chemist - 5 days on-site A small, well-established CDMO in Irvine, CA, wants to add a Senior QC Chemist to their team. Join this team to expand on your analytical experience in a cGMP environment. The organization supports its employees' growth and development, helping employees succeed in the pharmaceutical industry while supporting their network of clients. Currently, the team is only considering candidates local to Irvine, CA, or candidates who have a sustainable commute to their labs. Day to day: Analytical testing of raw materials, in-process samples, and final products Predominately utilize analytical instrumentation, and ensure proper functioning Carry out the development of analytical methods, and author SOPs Provide peer review for other technician's data Maintain and troubleshoot HPLC and other analytical instrumentation, and maintain equipment calibration and qualification Support management with training of team members, laboratory investigations, and internal/external audits Experience: Bachelor of Science in Chemistry or related field 8+ years of experience in the pharmaceutical/biotech environment Exposure to working with small molecules Experience working with HPLC, GC, CE, ICP, FTIR, and dissolution apparatus.
US$80000 - US$90000 per year + Medical, Dental, and Vision Insurance
Irvine
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Supplier Quality Management Engineer
Responsibilities: Assist the strategic sourcing team in reviewing, negotiating and reformulating existing quality agreements with suppliers Support in the creation of new quality agreements with new or existing suppliers Supporting the strategic procurement team in supplier audits You act as a link between the operational procurement team and suppliers You will act as a subject matter expert for all related supplier quality procedures and ensure compliance with relevant procedures Supporting production in case of supplier problems Creation of inspection plans for incoming goods Supporting Quality Engineers in reviewing and approving the test strategy, test plans and test reports in the implementation of product and process changes and their verifications Supporting Quality Engineers in ensuring the regulatory conformity of processes and products within the framework of quality assurance, taking into account the quality methods according to ISO 13485 and 21 CFR Parts 11 and 820 Requirements: Scientific or technical studies (e.g. mechanical engineering, electrical engineering, materials science, physics, process engineering, etc.) Experience in the field of quality assurance and compliance with regulations and quality standards of the medical device industry (21 CFR Part 11 and 820, Regulation (EU) 2017/745, ISO 13485, ISO 14971, ISO 9001) Experience in the field of risk management, ideally in medical technology Confident appearance and enjoyment in moderating discussions Fluent in German and English or willingness to learn them independently Basic knowledge of the use of Jira & Confluence is an advantage
Negotiable
Switzerland
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Associate Director Clinical GCP Quality
Our client is an industry-leading biotechnology company that specializes in developing groundbreaking cancer therapies that harness the power of cutting-edge technologies. They are currently seeking a highly experienced professional to join their team as the Associate Director of Clinical (GCP) Quality. Responsibilities: Proven track record in effectively managing and supervising CAPA plans, including writing, reviewing, approving, and closing them. Demonstrated capability in conducting and overseeing site, internal GCP, and vendor audits, along with directing and guiding audit follow-up actions. Proficiency in establishing Quality and Cross-Functional Standard Operating Procedures (SOPs) and processes, along with implementing associated document controls. Experience serving as a global document management system administrator. Skilled in managing and mentoring direct reports. Ability to coordinate cross-functional meetings between departments and Quality teams. Willingness to undertake other duties as assigned. Qualifications: Bachelor's degree or higher qualification within life sciences At least 10 years' experience working in GCP Quality Assurance and/or GCP Compliance, additional GCP Auditing experience preferred In-depth knowledge of global regulations related to good clinical practice Excellent interpersonal communication skills along with proficiency communicating both verbally and written formats. Bilingual Willingness to travel If you are interested, please apply with your CV attached.
Negotiable
Tokyo
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