Quality Systems Specialist
2 days ago
Waunakee
Job Description Quality Systems Specialist – Auditing and Vendor Management Job Description The Quality Systems QA Specialist supports current Good Manufacturing Practice (cGMP) quality system activities within a biopharmaceutical manufacturing environment, with a strong focus on auditing and vendor management. This role executes and maintains quality processes within a MasterControl-based electronic Quality Management System (eQMS), builds and manages a supplier and vendor quality program, and ensures alignment with internal procedures and global regulatory requirements. The specialist plays a key role in GMP training programs, validation and qualification document review, deviations, investigations, corrective and preventive actions (CAPAs), change controls, and Annual Product Review (APR) preparation, while collaborating closely with cross-functional teams. Responsibilities • Execute, maintain, and continuously improve cGMP quality system processes within the MasterControl electronic Quality Management System (eQMS)., • Build, implement, and manage a comprehensive supplier and vendor quality program, including qualification and ongoing oversight of suppliers of raw materials, chemicals, and other critical goods and services., • Plan, perform, and document supplier and vendor audits, both domestically and internationally, to assess compliance with cGMP, internal procedures, and applicable regulatory expectations., • Coordinate and support internal audits to evaluate the effectiveness of the quality management system and identify opportunities for improvement., • Review, assess, and approve validation and qualification documentation to ensure compliance with cGMP and internal quality standards., • Manage and support GMP training programs, including coordination, documentation, and maintenance of training records within the quality system., • Review batch records and related documentation for accuracy, completeness, and compliance prior to release or further processing., • Lead or support the investigation of deviations and nonconformances, ensuring thorough root cause analysis and appropriate documentation., • Initiate, manage, and monitor corrective and preventive actions (CAPAs) to address identified issues and prevent recurrence, ensuring timely closure and effectiveness checks., • Oversee and govern change control processes, including initiation, impact assessment, approval, and implementation of changes affecting products, processes, or systems., • Support the preparation and coordination of Annual Product Reviews (APRs), compiling and analyzing quality data and trends., • Maintain robust document control practices, ensuring controlled creation, review, approval, distribution, and archival of quality documentation., • Collaborate cross-functionally with manufacturing, quality control, supply chain, and other stakeholders to ensure quality and regulatory compliance across the product lifecycle., • Support continuous improvement initiatives within the quality management system by identifying process gaps, proposing enhancements, and implementing best practices., • Ensure compliance with FDA regulations and other applicable global regulatory requirements in all quality system and vendor management activities., • Maintain accurate and complete quality records, including audit reports, vendor qualification files, training records, and change control documentation., • Travel domestically and internationally, as required, to conduct supplier and vendor audits and support on-site quality activities. Essential Skills • Bachelor’s degree or above in a scientific discipline., • 5+ years of quality experience in the biopharmaceutical or pharmaceutical industry, with a preference for experience specifically in managing vendors and conducting audits., • Demonstrated experience with quality assurance and quality systems in a cGMP manufacturing environment., • Hands-on experience with quality auditing, including planning, executing, and documenting internal and external audits., • Proficiency in vendor management, including supplier qualification, performance monitoring, and issue resolution., • Experience managing deviations, investigations, and root cause analysis in a regulated environment., • Proven ability to initiate, manage, and close CAPAs, including effectiveness verification., • Familiarity with FDA regulations and global regulatory expectations for biopharmaceutical or pharmaceutical manufacturing., • Experience with document control processes and systems, including controlled document lifecycle management., • Experience with batch record review and related documentation in a GMP setting., • Working knowledge of electronic Quality Management Systems (eQMS), preferably MasterControl or a similar platform., • Strong understanding of quality management system principles and practices in a biopharmaceutical or pharmaceutical context., • Willingness and ability to travel up to 50% of the time domestically and internationally for supplier and vendor audits., • Strong written and verbal communication skills to interact effectively with internal teams and external suppliers., • Ability to work independently and collaboratively in a cross-functional environment while managing multiple priorities. Additional Skills & Qualifications • Experience supporting or managing GMP training programs, including training documentation and compliance tracking., • Experience in validation and qualification document review within a regulated manufacturing environment., • Experience overseeing or supporting change control governance, including impact assessments and approvals., • Exposure to Annual Product Review (APR) preparation, data collection, and trend analysis., • Prior experience with continuous improvement initiatives within quality systems or operational processes., • Familiarity with internal audit programs and coordination of audit schedules and follow-up actions., • Ability to interpret and apply quality and regulatory requirements to vendor and supplier quality programs., • Strong organizational skills and attention to detail in managing quality records and documentation., • Capability to work effectively in a growing quality organization and adapt to evolving processes and systems. Work Environment This position operates within a biopharmaceutical manufacturing environment that emphasizes strong cGMP and regulatory compliance. The role primarily works on a first-shift schedule, Monday through Friday, with a flexible start time between 7:00 a.m. and 9:00 a.m., and standard eight-hour workdays. The quality team currently includes Quality Management System Specialists and Document Control Technicians, with plans for further team expansion, creating a collaborative and supportive environment focused on quality excellence. Work is performed both in an office setting and within a controlled manufacturing and quality environment, using an electronic Quality Management System (eQMS), specifically MasterControl, and other standard quality and documentation tools. The role involves regular coordination with cross-functional teams and requires domestic and international travel to supplier and vendor sites for audits and quality oversight. Job Type & Location This is a Permanent position based out of Waunakee, WI. Pay and Benefits The pay range for this position is $62000.00 - $90000.00/yr. Competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k Workplace Type This is a fully onsite position in Waunakee,WI. Application Deadline This position is anticipated to close on Jun 26, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.