Quality Systems Specialist
2 days ago
Madison
Job DescriptionJob Title: Quality Systems SpecialistJob Description The Quality Systems Specialist supports cGMP quality system activities within a biopharmaceutical manufacturing environment by executing and maintaining processes managed through the MasterControl electronic Quality Management System (eQMS). This role manages the GMP training program and associated documentation, reviews and approves validation and qualification documents, and ensures that quality systems remain compliant with internal procedures and applicable regulatory requirements. The specialist drives continuous improvement across quality systems, supports investigations and corrective actions, and contributes to a robust, audit-ready quality culture. Responsibilities • Execute and maintain cGMP quality system processes within a biopharmaceutical manufacturing environment using the MasterControl electronic Quality Management System (eQMS)., • Manage the GMP training program, including creation, maintenance, and control of training documentation, ensuring personnel receive appropriate and timely training., • Review and approve validation and qualification documents to ensure they meet internal quality standards and regulatory expectations., • Facilitate, document, and review investigations related to process deviations, product failures, customer complaints, and facility incidents, ensuring adherence to established procedures., • Ensure all investigations are properly documented, justified, and closed within defined timelines, maintaining compliance with quality and regulatory requirements., • Support the initiation, implementation, and effectiveness review of Corrective and Preventive Actions (CAPAs) and change controls to address root causes and prevent recurrence., • Review and verify compliance with Quality Systems QA procedures, recommending and implementing improvements where needed., • Drive continuous improvement initiatives within the quality management system to enhance efficiency, compliance, and documentation quality., • Oversee the preparation and compilation of Annual Product Reviews (APRs), ensuring accuracy, completeness, and timely completion., • Manage Change Control Committee meetings, including scheduling, documentation, decision tracking, and follow-up on assigned actions., • Support the supplier and vendor quality program through supplier qualification activities, including document review, risk assessment, and ongoing monitoring., • Participate in supplier and vendor auditing activities, including planning, execution, and documentation of audit results., • Coordinate internal and external audits, including scheduling, logistics, document preparation, and communication with stakeholders., • Review vendor and supplier qualification reports to ensure they meet quality and regulatory expectations and that appropriate actions are taken for identified gaps., • Coordinate and track responses to audit observations and findings, ensuring timely and effective remediation., • Participate in audits as a subject matter resource for quality systems, document control, batch record review, and compliance activities., • Address audit findings as necessary by supporting root cause analysis, CAPA development, and verification of effectiveness., • Collaborate cross-functionally with manufacturing, validation, operations, and other quality functions to maintain compliance with internal procedures and applicable regulatory requirements., • Support quality assurance activities such as batch record review, document control, and quality system documentation to ensure data integrity and regulatory compliance., • Contribute to a culture of quality, accountability, and continuous improvement within the quality management system and broader organization.Essential Skills, • Bachelors degree or above in a scientific discipline., • Minimum of 2+ years of Quality experience in the biopharmaceutical or pharmaceutical industry., • Hands-on experience with cGMP quality systems within a manufacturing or regulated environment., • Experience working with an electronic Quality Management System (eQMS), preferably MasterControl., • Demonstrated experience in quality assurance, including quality auditing and internal audit activities., • Experience conducting or supporting investigations into process deviations, product failures, customer complaints, and facility incidents., • Proficiency in CAPA management, including root cause analysis, corrective and preventive action planning, and effectiveness verification., • Experience with change control processes and participation in or coordination of change control committees., • Knowledge of FDA regulations and applicable regulatory requirements for biopharmaceutical or pharmaceutical manufacturing., • Experience with document control and quality documentation practices, including controlled documents and records management., • Experience with batch record review and ensuring completeness, accuracy, and compliance of production documentation., • Familiarity with quality management systems, including compliance with Quality Systems QA procedures., • Strong vendor management and supplier qualification experience, including supplier auditing and monitoring., • Ability to coordinate and support internal and external audits, including preparing responses to audit observations., • Strong attention to detail and ability to maintain accurate, compliant documentation., • Effective communication skills, with the ability to collaborate across functions and present quality-related information clearly., • Strong organizational and time management skills to manage multiple tasks, investigations, and projects concurrently.Additional Skills & Qualifications, • Bachelors degree or above in a scientific discipline with 5+ years of Quality experience in the biopharma or pharmaceutical industry preferred., • Experience in quality roles within related regulated industries such as food and beverage or medical device is considered beneficial., • Experience supporting or preparing Annual Product Reviews (APRs)., • Experience managing or supporting supplier and vendor quality programs., • Familiarity with MasterControl or similar eQMS platforms for document control, training, and quality processes., • Demonstrated ability to drive continuous improvement initiatives within quality systems., • Experience participating in or leading cross-functional meetings such as Change Control Committees., • Ability to interpret and apply regulatory guidelines and internal procedures to practical quality system activities., • Comfort working in a team environment with other Quality Management System Specialists and Document Control Technicians.Work Environment This role operates in a biopharmaceutical manufacturing environment with a strong focus on cGMP compliance and electronic quality systems. The position follows a first-shift schedule, Monday through Friday, with a start time between 7:00 a.m. and 9:00 a.m. and an eight-hour workday. The quality systems team is based in a dedicated building and includes multiple Quality Management System Specialists and Document Control Technicians, fostering a collaborative and supportive team environment. Work is primarily office-based within a regulated facility, using tools such as the MasterControl electronic Quality Management System (eQMS) and other quality and documentation systems to manage training, document control, batch records, audits, and supplier quality activities. Job Type & Location This is a Permanent position based out of Madison, WI. Pay and Benefits The pay range for this position is $62000.00 - $78000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Employees are eligible for Medical, Dental and Vision on day 1 of employment. The company provides Basic Life insurance, Basic AD&D insurance along with Short-term disability on all full-time employees. Employees have the option to elect Voluntary Life, Voluntary AD&D along with Long-term disability coverage. Health and Flexible spending account options. Full-time employees can contribute to their 401k upon hire and are eligible for a company contribution. 160 hours of vacation & 40 hours of sick time (both pro-rated base on hire date) and 9 paid holidays. Job Type & Location This is a Permanent position based out of Madison, WI. Application Deadline This position is anticipated to close on Nov 3, 2026. Workplace Type This is a fully onsite position in Madison,WI. 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.
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