Scientific Quality Analyst

Actalent; Dayton (OH); On-site; USD 34,000 - 36,000; Full time

Benefits offered by this job

Health insurance

On-site parking

401(k) plan

Job summary

Actalent is hiring a Quality Analyst I to support a regenerative medicine laboratory in the north Dayton, OH area. The role is desk-based, focusing on documentation reviews, CAPA tracking, NCRs, and QMS support to CGMP operations.

Ideal candidates hold a Bachelor’s degree in a Life Science field and have 6 months to 1+ year of regulated industry experience (pharma, medical devices, etc.). Strong attention to detail and knowledge of FDA/ISO requirements are desired.

Qualifications

• Bachelor's degree in Life Science or related field.
• 6 months to 1+ year of experience in a regulated environment.

Responsibilities

• Review batch production records and manufacturing records for lot release.
• Coordinate CAPA, NCR, and Deviation records to close on time.
• Support environmental monitoring and QA documentation.
• Assist CGMP departments with QMS operations.
• Maintain records per GDP standards.

Skills

Regulatory environment experience

Attention to detail

Documentation review skills

CAPA tracking

Education

Bachelor's degree in Life Science or related field

Tools

GxP knowledge

CGMP knowledge

Job description

We are actively hiring for Quality Analysts to support a regenerative medicine laboratory here in the north Dayton, OH area. This role will primarily involve reviewing documentation to support the lab, coordinating and tracking Corrective and Preventative Actions (CAPAs), and other desk related duties. This role will not be in the lab, and will be more of a desk based role.

Ideal candidates will have a Bachelors Degree in a scientific field and at minimum 6 months-1+ year of experience working in a highly regulated environment (food manufacturing, pharmaceutical, cosmetic, etc.).

Job Description

The Quality Analyst I performs quality control inspection and disposition of materials and products according to established specifications and regulatory requirements. This role conducts inspections using appropriate measuring instruments and methods, manages non-conforming materials and products within the established Quality System, and ensures adherence to applicable FDA, OSHA, and ISO regulations and standards. The position involves working under limited supervision, supporting lot release activities, and contributing to continuous improvement of quality processes in a rapidly growing, state-of-the-art facility.

Responsibilities

• Perform reviews of batch production records and manufacturing records as part of lot release activities.
• Coordinate and track Corrective and Preventive Action (CAPA), Non-Conforming Report (NCR), and Deviation records, ensuring all tasks are completed on time.
• Coordinate and track the site environmental monitoring (EM) testing program.
• Assist teams in coordinating problem solving and root cause analysis for quality events.
• Ensure the development, review, and release of quarterly environmental monitoring trending reports and promptly upscale significant trends to management.
• Provide input based on knowledge and experience with batch release requirements.
• Provide Quality Management System (QMS) operations support to all current Good Manufacturing Practice (CGMP) departments.
• Perform Quality Control activities at processing or distribution sites, including incoming material inspections, in-process inspections, and finished product inspections.
• Inspect a range of products including medical devices, sterile processed human tissue-based products, unprocessed human tissue, component supplies, and labeling materials.
• Maintain accurate and complete records of Quality Control activities in accordance with Good Documentation Practices (GDP).
• Provide support related to gowning qualification and training.
• Ensure timely issuance, review, and approval of microbiology and environmental monitoring testing results.
• Interface with colleagues to ensure effective corrective and preventive actions are implemented for recurring product or process discrepancies.
• Assist in the review and approval of equipment qualifications.
• Assist in the review of calibration and preventive maintenance activities.
• Assist in hosting onsite regulatory audits and inspections.

Qualifications

• Bachelors degree in a Life Science discipline or a related field.
• Minimum of 12 years of relevant industry experience with GMP, GDP, or GxP within a medical device, pharmaceutical, or tissue commercial organization preferred.

Shifts Available

• 2nd Shift: Monday - Friday, 3pm - 11:30pm
• 3rd Shift: Monday - Friday, 11pm - 7:30am

Job Type & Location

This is a Permanent position based out of Dayton, OH.

Pay and Benefits

The pay range for this position is $25.00 - $26.50/hr.

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.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Dayton,OH.

Application Deadline

This position is anticipated to close on Oct 9, 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.