Quality Assurance Specialist

Actalent; Waunakee (WI); On-site; USD 62,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Excellent benefits

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

HSA options

EAP

Paid holidays

401k

Job summary

Actalent in Waunakee, WI is seeking a detail-oriented Quality Assurance Specialist to support GMP-compliant quality systems in a regulated manufacturing environment. You will review batch records, manage deviations and CAPAs, and work with cross-functional teams to ensure product quality and regulatory readiness.

This on-site, Monday–Friday role offers comprehensive benefits and opportunities to contribute to continuous improvement within a collaborative quality organization.

Qualifications

• Bachelor's degree in a scientific discipline.
• 2+ years in regulated GMP/FDA/ISO environment for QA.
• Experience in pharma/biotech/medical device industries.
• Strong knowledge of GMP, FDA, and ISO requirements.
• Batch record and quality documentation review experience.
• Experience managing deviations, investigations, CAPAs, and change controls.
• Familiar with document control and DCRs.
• Experience supporting audits and inspections in a regulated environment.
• Proficiency with electronic quality management systems (eQMS).
• Detail-oriented and organized.
• Excellent written and verbal communication.

Responsibilities

• Review batch records for accuracy and compliance.
• Inspect and approve incoming raw materials.
• Manage deviations, investigations, CAPAs, and change controls.
• Perform shipping release activities.
• Support Annual Product Review documentation.
• Maintain quality records and document control.
• Analyze quality data for trends and improvements.
• Coordinate quality training and maintain records.
• Use eQMS for document control and change management.
• Collaborate with production to resolve quality concerns.
• Support audits by ensuring documentation is available.
• Contribute to continuous quality system improvement.

Skills

GMP knowledge

FDA knowledge

ISO knowledge

Batch record review

Documentation review

Deviations & CAPAs

eQMS proficiency

Audits support

Attention to detail

Communication skills

Education

Bachelor's degree in Biology, Chemistry, Microbiology, Pharmaceutical Sciences, or another scientific discipline

Tools

eQMS

Job description

About The Role

We are seeking a detail-oriented Quality Assurance Specialist to support quality systems, compliance initiatives, and continuous improvement efforts within a regulated manufacturing environment. This role is responsible for ensuring adherence to GMP, FDA, and ISO requirements through batch record review, deviation management, document control, and quality system support. The ideal candidate will have experience in Quality Assurance within a regulated industry and enjoy working with quality systems, documentation, investigations, and cross-functional teams to maintain the highest standards of compliance and product quality.

Key Responsibilities

• Review batch records to ensure accuracy, completeness, and compliance with GMP, FDA, and ISO requirements.


• Inspect and approve incoming raw materials to verify quality standards and documentation requirements are met.


• Manage deviations, investigations, CAPAs, and change controls, ensuring timely resolution and effective corrective actions.


• Perform shipping release activities and verify products meet all quality requirements prior to release.


• Support the preparation and maintenance of Annual Product Review documentation.


• Maintain quality records and support document control activities, including document change requests (DCRs).


• Compile, organize, and analyze quality data to support reporting, trending, and continuous improvement initiatives.


• Coordinate quality-related training activities and maintain training records.


• Utilize electronic quality management systems (eQMS) for document control, change management, and quality record administration.


• Collaborate with production and cross-functional teams to resolve quality concerns and improve compliance.


• Support internal, customer, and regulatory audits by ensuring documentation is accurate, complete, and readily available.


• Contribute to the continuous improvement of quality systems, procedures, and documentation practices.

Qualifications

• Bachelor's degree in Biology, Chemistry, Microbiology, Pharmaceutical Sciences, or another scientific discipline.


• 2+ years of experience in a regulated GMP, FDA, or ISO environment for Quality Assurance Specialist-level candidates.


• Experience working in Quality Assurance within the pharmaceutical, biotechnology, medical device, or other highly regulated industries.


• Strong knowledge of GMP, FDA, and ISO requirements.


• Experience performing batch record review and quality documentation review.


• Experience managing deviations, investigations, CAPAs, and change controls.


• Familiarity with document control processes and document change requests (DCRs).


• Experience supporting audits and inspections in a regulated environment.


• Proficiency with electronic quality management systems (eQMS).


• Strong attention to detail and organizational skills.


• Excellent written and verbal communication abilities.


• Ability to manage multiple priorities while maintaining compliance and documentation accuracy.

Work Environment

This is an on-site, office-based Quality Assurance role operating on an Monday through Friday, first-shift schedule. The position is primarily located within the Quality Assurance office area and involves regular interaction with electronic quality management systems and quality documentation. The role provides a stable weekday schedule while offering opportunities to collaborate closely with production, operations, and other departments to support compliance and quality initiatives. The environment emphasizes organization, accuracy, teamwork, and adherence to regulatory standards.

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.

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.

• 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 Oct 29, 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 [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.