Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Job Description

The Quality Assurance Specialist works primarily on the production floor to support operations by performing verifications, conducting walkthroughs, and carrying out onsite reviews and mini audits to ensure processes consistently meet established quality and regulatory standards. This role actively participates in problem-solving activities, including initiating deviations when issues arise, and supports robust documentation practices by reviewing executed batch records, cleaning records, logbooks, and issuing batch records as needed. The position combines hands-on floor presence with focused office-based documentation and system work, contributing directly to the reliability and compliance of pharmaceutical manufacturing operations.

Responsibilities

• Spend the majority of time on the production floor supporting the operations team with in-process verifications and quality checks.
• Perform regular walkthroughs of production areas to observe activities, identify potential issues, and verify adherence to procedures and standards.
• Conduct onsite reviews and mini audits to ensure processes, documentation, and behaviors align with GMP, FDA, and ISO requirements.
• Initiate and support deviations when nonconformances or process issues are identified, contributing to timely and effective resolution.
• Review executed batch records for accuracy, completeness, and compliance prior to release or further processing.
• Review cleaning records and logbooks to confirm that equipment and areas meet cleanliness and documentation requirements.
• Issue batch records as needed to support production schedules and ensure proper document control.
• Support CAPA-related activities by providing input from floor observations and audits, and by helping to verify implementation of corrective and preventive actions.
• Interact with document control processes to maintain accurate, current, and properly archived quality documentation.
• Use the electronic quality management system (eQMS) to review, track, and document quality events, records, and approvals.
• Follow and enforce appropriate gowning requirements, ranging from safety shoes to full gowning, depending on the area and process.
• Collaborate closely with production and other cross-functional teams to promote a strong quality culture and continuous improvement mindset.
• Maintain a visible presence on the floor (approximately 8085% of the time) while completing documentation and system work in an office environment for the remaining time.

Essential Skills

• Experience in a regulated industry environment (GMP, FDA, and/or ISO), with at least 2+ years.
• Pharmaceutical or closely related regulated manufacturing operations.
• Hands-on quality assurance experience, including batch record review and document control.
• Knowledge of GMP, FDA, and ISO quality and compliance requirements.
• Experience with audits or mini audits within a production or quality setting.
• Familiarity with CAPA processes and deviation management.
• Ability to review and interpret batch records, cleaning records, and logbooks with strong attention to detail.
• Comfort working extensively on the production floor in a highly regulated environment.
• Ability to follow and apply gowning and safety requirements in different production areas.
• Effective communication skills to collaborate with operations and other cross-functional teams.
• Ability to work independently while managing multiple tasks in a fast-paced environment.

Additional Skills & Qualifications

• Bachelors degree in a science discipline is preferred.
• 2+ years of regulated industry experience in GMP/FDA/ISO environments; candidates with approximately 10 years of experience and an associate degree may be considered.
• Experience supervising or leading others is beneficial for Lead-level positions, though the role will not have direct reports.
• Prior experience working with an electronic quality management system (eQMS) is a plus.
• Demonstrated ability to support problem solving and continuous improvement within quality and production processes.

Work Environment

This role is based on-site in a pharmaceutical production facility, with approximately 8085% of the time spent on the production floor and the remaining time in an office setting near production. The work environment includes clean, regulated manufacturing areas with defined gowning requirements that vary by zone, ranging from safety shoes to full gowning for higher-grade areas. The Quality Assurance Specialist interacts regularly with an electronic quality management system (eQMS) and performs documentation work in a shared or individual office space. The position follows structured shifts, with the current opening on a 3rd shift schedule of MondayThursday, 9:00 PM to 7:00 AM, operating as a 10-hour overnight shift. New hires complete training on 1st shift, MondayFriday from 8:00 AM to 4:30 PM, typically over 68 weeks depending on experience and skills, and training classes may be grouped so that team members on the same shift start together. The environment emphasizes strong compliance with GMP, FDA, and ISO standards, close collaboration with operations, and consistent adherence to safety and gowning protocols.

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 - $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 Waunakee, WI.

Application Deadline

This position is anticipated to close on Nov 16, 2026.

Workplace Type

This is a fully onsite position in Waunakee,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.