Laboratory Quality Analyst

Actalent; Dayton (OH); Vor Ort; USD 34.000 - 37.000; Vollzeit

Benefits dieser Stelle

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Time Off/Leave (PTO)

Zusammenfassung

Actalent is hiring a Quality Specialist to support QA and QC in a regenerative medicine laboratory and manufacturing setting. The role focuses on documentation review, investigations, CAPA management, deviation tracking, and compliance with established regulations and GDP.

You will work with cross-functional teams to ensure batch release readiness and maintain cGMP documentation, while participating in audits and training activities in a fully onsite Dayton, OH environment.

Qualifikationen

• 6+ months of experience in a regulated laboratory, manufacturing, quality, or similar highly regulated environment.
• Experience with quality systems, CAPAs, deviations, investigations, NCRs, or document control processes is preferred.

Aufgaben

• Review batch records and manufacturing documentation for lot release.
• Coordinate CAPAs, NCRs, and deviation records with timely completion and follow-up.
• Support investigations and root-cause analyses for quality events and process improvements.
• Coordinate environmental monitoring programs and related documentation.
• Assist with development, review, and release of environmental monitoring trend reports.
• Provide support for batch release requirements and quality compliance processes.
• Support QMS activities across cGMP departments.
• Perform QC activities including incoming, in-process, and finished product inspections.
• Inspect medical devices, tissue-based products, raw materials, and labeling for quality.
• Maintain thorough documentation per GDP.
• Support gowning qualification programs and training.
• Review microbiology and environmental monitoring test results.
• Collaborate on CAPA implementations for recurring quality concerns.
• Assist with equipment qualification reviews, calibration docs, and preventive maintenance.
• Participate in regulatory inspections, customer audits, and internal audits.

Kenntnisse

Laboratory experience

Regulatory awareness

Ausbildung

Bachelor's degree in Biology, Chemistry, Microbiology, Biochemistry, or related field

Jobbeschreibung

We are actively hiring multiple long-term career opportunities for Laboratory Quality Analysts to support a growing company in the regenerative medicine field!

This is an excellent opportunity for recent science graduates and early-career professionals with laboratory or regulated industry experience who are interested in transitioning into a highly visible Quality role. You will work closely with laboratory, manufacturing, and quality teams to help ensure products meet the highest standards of safety, compliance, and quality.

In this position, you'll gain hands-on experience with Quality Systems, investigations, CAPAs, deviation management, regulatory compliance, and batch record review while supporting critical operations in a fast-paced, collaborative environment.

Position Overview

The Quality Specialist is responsible for supporting Quality Assurance and Quality Control activities for a regenerative medicine laboratory and manufacturing environment. This role is primarily desk-based and focuses on documentation review, investigations, CAPA management, deviation tracking, and compliance activities to ensure adherence to established regulations, procedures, and quality standards.

Key Responsibilities

• Review batch production records and manufacturing documentation as part of product lot release activities.
• Coordinate and track Corrective and Preventive Actions (CAPAs), Non-Conformance Reports (NCRs), and deviation records, ensuring timely completion and follow-up.
• Support investigations, root cause analysis, and problem-solving efforts related to quality events and process improvements.
• Coordinate and track environmental monitoring (EM) programs and associated documentation.
• Assist with the development, review, and release of environmental monitoring trend reports while escalating significant findings when appropriate.
• Provide support and guidance related to batch release requirements and quality compliance processes.
• Support Quality Management System (QMS) activities across current Good Manufacturing Practice (cGMP) departments.
• Perform Quality Control activities, including incoming material inspections, in-process inspections, and finished product inspections.
• Inspect medical devices, sterile processed human tissue-based products, raw materials, component supplies, and labeling materials for compliance with quality standards.
• Maintain thorough and accurate documentation in accordance with Good Documentation Practices (GDP).
• Support gowning qualification programs and training activities.
• Review and approve microbiology and environmental monitoring test results in a timely manner.
• Collaborate with cross-functional teams to implement effective corrective and preventive actions for recurring quality concerns.
• Assist with equipment qualification reviews, calibration documentation, and preventive maintenance activities.
• Participate in regulatory inspections, customer audits, and internal audit activities as needed.

Qualifications

Required

• Bachelor's degree in a scientific discipline such as Biology, Chemistry, Microbiology, Biochemistry, or a related field.
• Minimum of 6 months of experience working in a regulated laboratory, manufacturing, quality, or other highly regulated environment.

Preferred

• Experience working within biotechnology, pharmaceutical, medical device, tissue banking, or related life sciences industries.
• Exposure to cGMP, Quality Systems, CAPAs, deviations, investigations, NCRs, or document control processes.
• Experience reviewing technical documentation, laboratory records, or manufacturing records.

Why Consider This Opportunity?

• Join an innovative organization at the forefront of regenerative medicine and nerve regeneration.
• Build valuable experience in Quality Assurance, Quality Systems, and regulatory compliance.
• Gain exposure to investigations, CAPAs, deviations, audits, and cGMP operations.
• Work cross-functionally with laboratory, manufacturing, and quality professionals.
• Develop highly transferable skills that can accelerate long-term career growth within the biotechnology, pharmaceutical, and medical device industries.
• Note: This opportunity is ideal for early-career scientific professionals seeking to grow within Quality and regulatory operations. Candidates with Bachelor's-level scientific backgrounds and relevant laboratory or regulated industry experience are strongly encouraged to apply.

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)

Application Deadline

This position is anticipated to close on Nov 10, 2026.

Workplace Type

This is a fully onsite position in Dayton,OH.

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.