URGENTLY HIRING: Quality Documentation Specialist

Actalent; Vandalia (OH); Presencial; USD 34 000 - 37 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental & vision

401(k) retirement plan

Disability insurance

Paid time off

Resumo da oferta

Actalent is hiring multiple Quality Specialists in Dayton, OH for a contract-to-hire role at a regulated regenerative medicine lab. You will perform desk-based document review, CAPAs, investigations, deviations, and other duties to ensure compliance with CGMP and GDP.

The ideal candidate has a Bachelor's degree in a scientific discipline and at least 6 months in a regulated laboratory. PhD candidates will be considered for advanced roles.

Qualificações

• Bachelor's degree in a scientific discipline.
• Minimum of 6 months of experience in a heavily regulated industry.

Responsabilidades

• Review batch production records and manufacturing records as part of lot release activities.
• Coordinate and track CAPA, NCR, and Deviation records to ensure timely completion.
• Coordinate and track environmental monitoring testing program.

Conhecimentos

Document Review

Regulated environment

Formação académica

Bachelor's degree in a scientific discipline

Descrição da oferta de emprego

We are actively hiring for multiple Quality Specialists within the regenerative medicine space here in Dayton, OH! These roles will primarily be desk based and performing documentation review, handling Corrective and Preventative Actions, performing investigations, handling deviations, and supporting other areas as needed.

These are all supporting the lab and manufacturing to ensure they are continuing to follow necessary regulations and protocols. Candidates should have a Bachelors Degree in a Scientific discipline and at least 6 months of experience working in a regulated laboratory or similar environment. Candidates with a PhD level education will be considered.

Job Description

The Quality Specialist will be supporting a regenerative nerve and medicine laboratory by performing desk based document review, handling CAPAs, investigations, deviations, and performing other duties to ensure proper regulations and protocols are being followed.

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 elevate 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 scientific discipline.
• Minimum of 6+ months of experience working in a heavily regulated industry.

Job Type & Location

This is a Contract to Hire 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)

Job Type & Location

This is a Contract to Hire position based out of Vandalia, OH.

Application Deadline

This position is anticipated to close on Oct 31, 2026.

Workplace Type

This is a fully onsite position in Vandalia,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.