Quality Assurance Specialist

Actalent; Madison (WI); On-site; USD 62,000 - 78,000; Full time

Benefits offered by this job

Health, Dental, Vision insurance

401(k) plan

Paid time off

Job summary

Actalent is seeking a Quality Assurance Specialist for an on-site role in Madison, WI, within a regulated pharmaceutical manufacturing environment. You will partner with operations to verify processes, conduct walk-throughs, review batch records, and support on-the-floor quality reviews to ensure GMP, FDA, and ISO compliance.

The role emphasizes CAPA, deviations, document control via EQMS, and collaboration across production, quality, and cross-functional teams.

Qualifications

• Quality assurance experience in a regulated industry environment, with exposure to GMP, FDA, or ISO requirements.
• At least 2 years of experience in a regulated industry (GMP/FDA/ISO), at least 5 years preferred.
• Bachelor's degree in a science discipline preferred, Associates Degree required.
• Hands-on experience with batch records, including issuance, execution review, and batch record review.
• Knowledge of CAPA processes, including deviation initiation, investigation, and implementation of corrective and preventive actions.
• Experience with audits, mini audits, or on-the-floor quality reviews in a manufacturing or pharmaceutical setting.
• Familiarity with document control practices and requirements in a regulated environment.
• Ability to work primarily on the production floor while maintaining attention to detail and compliance.
• Comfort working with electronic quality management systems (EQMS) or similar digital quality tools.
• Willingness and ability to follow and enforce gowning and safety requirements in different production areas.

Responsibilities

• Spend approximately 80-85% of working time on the production floor supporting day-to-day operations and quality oversight.
• Perform routine walk-throughs of production areas to observe processes, verify compliance with procedures, and identify potential issues.
• Conduct on-site reviews and mini audits to ensure activities align with GMP and FDA/ISO requirements.
• Assist the operations team in performing in-process verifications and checks.
• Review executed batch records for completeness, accuracy, and compliance with procedures.
• Review cleaning records and other quality-related documentation for completeness and traceability.
• Issue batch records as needed and ensure they are controlled and reconciled.
• Identify quality issues or deviations and help define compliant solutions; initiate deviations when necessary.
• Support CAPA initiatives arising from deviations and audits; contribute to root cause investigations.
• Collaborate with production, quality, and cross-functional teams to promote a strong quality culture and continuous improvement.
• Interact with EQMS for document control, deviation management, CAPA tracking, and related quality workflows.
• Adhere to gowning and safety requirements across production areas.
• Maintain accurate, timely records of all quality activities on the floor and in the office.

Skills

GMP/FDA/ISO knowledge

On-floor QA

Document control

EQMS experience

Audit/mini-audits

CAPA handling

Verbal/written communication

Gowning/safety procedures

Education

Associates degree required

Science degree preferred

Tools

EQMS

Job description

Job Description

This role provides on-site quality assurance support on the production floor in a regulated pharmaceutical manufacturing environment. The Quality Assurance Specialist spends most of their time partnering with operations to perform verifications, conduct walk-throughs, and complete on-the-floor reviews and mini audits to ensure processes follow established procedures and regulatory requirements. The position also supports quality documentation activities, including issuing and reviewing batch records and other controlled documents, and helps identify and drive quality improvements through deviations and corrective actions. Multiple levels are available depending on experience.

Job Title: Quality Assurance Specialist

Responsibilities

• Spend approximately 8085% of working time on the production floor supporting day-to-day operations and quality oversight.
• Perform routine walk-throughs of production areas to observe processes, verify compliance with procedures, and identify potential issues.
• Conduct on-site reviews and mini audits to ensure activities align with Good Manufacturing Practices (GMP) and applicable FDA and ISO requirements.
• Assist the operations team in performing in-process verifications and checks to confirm that production steps occur as intended.
• Review executed batch records for completeness, accuracy, and compliance with established procedures.
• Review cleaning records, log books, and other quality-related documentation to ensure proper completion and traceability.
• Issue batch records as needed and ensure they are controlled, distributed, and reconciled according to document control procedures.
• Help identify quality issues or process deviations and contribute to defining practical, compliant solutions.
• Initiate deviations when necessary and support the investigation and documentation of root causes.
• Support the implementation and documentation of Corrective and Preventive Actions (CAPA) arising from deviations, audits, or other quality events.
• Collaborate closely with production, quality, and other cross-functional teams to promote a strong quality culture and continuous improvement.
• Interact with electronic quality management systems (EQMS) for document control, deviation management, CAPA tracking, and related quality workflows.
• Adhere to and promote proper gowning and safety practices, ranging from use of safety shoes to full gowning, depending on the area.
• Maintain accurate, timely, and compliant records of all quality-related activities performed on the floor and in the office.

Essential Skills

• Quality assurance experience in a regulated industry environment, with exposure to GMP, FDA, or ISO requirements.
• At least 2 years of experience in a regulated industry (GMP/FDA/ISO), at least 5 years preferred.
• Bachelors degree in a science discipline preferred, Associates Degree required.
• Hands-on experience with batch records, including issuance, execution review, and batch record review.
• Knowledge of CAPA processes, including deviation initiation, investigation, and implementation of corrective and preventive actions.
• Experience with audits, mini audits, or on-the-floor quality reviews in a manufacturing or pharmaceutical setting.
• Familiarity with document control practices and requirements in a regulated environment.
• Ability to work primarily on the production floor while maintaining attention to detail and compliance.
• Strong written and verbal communication skills for documenting findings, reviewing records, and collaborating with operations and quality teams.
• Comfort working with electronic quality management systems (EQMS) or similar digital quality tools.
• Willingness and ability to follow and enforce gowning and safety requirements in different production areas.

Work Environment

This position is based on-site in a pharmaceutical production facility, with approximately 8085% of time spent on the production floor and the remaining time in an office setting. The role required frequent movement between manufacturing areas and office or EQMS workstations, and involves regular interaction with production equipment, controlled environments, and quality systems. Gowning requirements vary by area, ranging from wearing safety shoes to being fully gowned in accordance with site procedures and safety protocols. Multiple shift options are available, including a 3rd shift (9:00 PM 7:00 AM, MondayThursday, 10-hour overnight shift), a Weekend Day Shift (6:00 AM 6:00 PM, FridaySunday, 12-hour shift), and a Weekend Night Shift (6:00 PM 6:00 AM, FridaySunday, 12-hour overnight shift). Training typically begins on 1st shift, MondayFriday from 8:00 AM to 4:30 PM, for approximately 68 weeks depending on skills. After training, team members transition to their assigned shift. The environment combines time on the production floor with time in office areas outside of production, including shared or individual office spaces, and requires regular use of an electronic quality management system (EQMS) for document control and quality workflows.

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.

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.

Equal Opportunity Employer

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.

Accommodation Request

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 [e-mail] 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.