Quality Analyst

Actalent; Vandalia (OH); On-site; USD 34,000 - 37,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) retirement plan

Life Insurance (Voluntary)

Job summary

Actalent is seeking a Quality Analyst to perform quality control inspections and dispositions in a Vandalia, OH facility. You will support lot release activities, manage CAPA/NCR/Deviation records, and contribute to continuous improvement of quality processes in a state-of-the-art environment.

The role requires a Life Science degree and 1–2 years of experience in GMP/GDP/GxP; familiarity with FDA, OSHA, ISO standards, and GDP practices is preferred.

Qualifications

• Bachelor’s degree in Life Science or related field.
• 1–2 years GMP/GDP/GxP in medical device, tissue, or pharma preferred.
• Experience in FDA-regulated environment preferred.

Responsibilities

• Review batch production and manufacturing records for lot release.
• Coordinate CAPA, NCR, and Deviation records.
• Monitor site environmental testing program.
• Support root cause analysis for quality events.
• Release quarterly environmental monitoring reports and escalate major trends.
• Provide QMS support to CGMP departments.

Skills

GxP experience

FDA-regulated environment

CAPA/NCR/Deviations

Microsoft Excel

SOPs/Work Instructions

Regulatory knowledge

Attention to detail

Education

Bachelor’s degree in Life Science

Tools

Microsoft Excel

Job description

Actively Interviewing for Quality Analysts in Dayton, OH!

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 escape 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.

Essential Skills

• Bachelor’s degree in a Life Science discipline or a related field.
• Minimum of 1-2 years of relevant industry experience with GMP, GDP, or GxP within a medical device, pharmaceutical, or tissue commercial organization preferred.
• Experience working in an FDA-regulated environment, particularly medical device, human tissue, or pharmaceutical manufacturing preferred.
• Demonstrated experience with Quality System elements for CAPA, Non-Conforming Reports (NCRs), and Deviations.
• Experience with Microsoft Excel.
• Experience writing Standard Operating Procedures (SOPs) and Work Instructions.
• Knowledge of biology and human tissue handling.
• Understanding of GMP, compliance, and quality assurance principles.
• Ability to interpret and apply regulatory and quality standards (FDA, OSHA, ISO).
• Strong attention to detail and commitment to Good Documentation Practices.

Additional Skills & Qualifications

• Biology, tissue, or cell-related disciplines.
• Experience with skin processing or human tissue-based products.
• Experience in pharmaceutical or medical device quality environments.
• Familiarity with microbiology and environmental monitoring programs.
• Strong problem-solving skills and experience supporting root cause analysis.
• Ability to collaborate effectively with cross-functional CGMP teams.
• Strong written and verbal communication skills for documentation and reporting.
• Comfort working in clean room and laboratory environments involving human tissue.

Work Environment

The role is primarily desk-based with a portion of time dedicated to hands-on inspection duties in processing or distribution areas. The Quality Analyst will occasionally work in clean rooms and laboratories and must be comfortable working around human tissue and tissue-based products. The facility is a brand-new, state-of-the-art site located in Vandalia, OH, reflecting a modern, growth-oriented environment with a focus on regulated medical, tissue, and pharmaceutical products. Work is performed on second or third shift, with typical schedules of Monday through Friday, approximately 3:00 p.m.–11:30 p.m. for second shift and 11:00 p.m.–7:30 a.m. for third shift, with some flexibility required. The position involves working with standard office technology, Microsoft Excel, and quality systems, as well as inspection tools and equipment used in clean rooms and controlled environments. Appropriate clean room attire and gowning procedures are required when entering controlled areas.

Job Type & Location

This is a Contract position based out of Vandalia, 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 Vandalia,OH. Application Deadline This position is anticipated to close on Oct 8, 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.