Quality Analyst

Job Title:

Quality Analyst Job Description The Quality Analyst I is responsible for performing quality control (QC) inspection and disposition of materials and products according to specifications. This role involves conducting QC inspections using measuring instruments and inspection methods where applicable. The Quality Analyst ensures that any non-conforming materials or products are managed according to the Quality System policies and procedures to maintain compliance with FDA, OSHA, and ISO regulations and standards. The position requires performing various tasks under limited supervision. Responsibilities Perform reviews of batch production and manufacturing records as part of lot release activities. Coordinate and track CAPA, NCR, and Deviation records, ensuring tasks are completed on time. Coordinate and track the site environmental monitoring (EM) testing program. Assist teams in coordination of problem-solving and root cause analysis for quality events. Ensure the development, review, and release of quarterly EM trending reports, and bring significant trends to management's attention. Provide input based on knowledge and experience with batch release requirements. Provide Quality Management System (QMS) operations support to all CGMP departments. Conduct Quality Control activities at processing or distribution sites, including inspections of incoming materials, in-process, and finished products. Maintain accurate and complete records of Quality Control activities following Good Documentation Practices. Provide support related to gowning qualification and training. Ensure timely issuance, review, and approval of Microbiology and EM testing results. Interface with colleagues to ensure effective corrective and preventive actions for recurring product/process discrepancies. Assist in reviewing and approving equipment qualifications. Assist in reviewing Calibration and Preventative Maintenance reviews. Assist in hosting onsite regulatory audits and inspections. Essential Skills Knowledge in biology, human tissue, and skin processing. Experience with GMP, GDP, or GXP within a Medical Device, Pharmaceutical, or Tissue commercial organization. Familiarity with FDA-regulated environments, particularly medical device, human tissue, or pharmaceutical manufacturing. Proficiency in Microsoft Excel. Experience writing Standard Operating Procedures and Work Instructions. Understanding of Quality System elements for CAPA, Non-Conforming Reports (NCRs), and Deviations. Additional Skills & Qualifications Bachelor's Degree in a Life Science discipline or related field. Minimum of 1-2 years of relevant industry experience. Experience in an FDA-regulated environment is preferred. Work Environment This position involves mostly desk-based work with some inspection duties. The role requires occasional entry into clean rooms and labs, necessitating comfort working around human tissue.

The work schedule includes shifts:

1st shift (M-F 7a-3:30p), 2nd shift (M-F 3p-11:30p), and 3rd shift (M-F 11p-7:30a). Flexibility with shift times is needed. The role is based in a brand-new, state-of-the-art facility in Vandalia, OH. 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. 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 Jul 16, 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 actalentaccommodation@actalentservices.com 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.