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Quality Analyst
Actalent
Performing quality control inspections and disposition of materials and products in the pharmaceutical industry, adhering to FDA, OSHA, and ISO regulations.
14d ago
$25 - $25
Entry-level, Junior (1-3 years)
Full Time
Vandalia, OH
Onsite
Company Size
5,000 Employees
Service Specialisms
Technical consultation
Performance analysis
Physical development
Injury prevention and recuperation
Sports psychology
360° Marketing
Consultancy with clubs and sporting entities
Legal services
Sector Specialisms
Utilities
Power
Automotive
Food and Beverage
Consumer Products
Industrial Goods
Manufacturing
Mechanical Engineering
Role
What you would be doing
review & approve
quality control
environmental monitoring
capa coordination
root cause analysis
gowning qualification
- Assist teams in problem-solving and root cause analysis for associated quality events.
- Perform reviews of batch production records and manufacturing records as part of lot release activities.
- Assist in the review and approval of equipment qualifications.
- Interface with colleagues to ensure effective corrective and preventive actions for recurring product/process discrepancies.
- Perform Quality Control activities at processing or distribution sites, including incoming material inspections, in-process inspections, and finished product inspections.
- Assist in the review of Calibration and Preventative Maintenance.
- Provide Quality Management System Operations support to all CGMP departments.
- Assist in hosting onsite regulatory audits and inspections.
- Maintain accurate and complete records of Quality Control activities, following Good Documentation Practices.
- Coordinate and track the site environmental monitoring testing program.
- Provide support related to gowning qualification and training.
- Provide input based on knowledge and experience with batch release requirements.
- Develop, review, and release quarterly environmental monitoring trending reports, ensuring significant trends are brought to management attention.
- Coordinate and track CAPA, NCR, and Deviation records, ensuring tasks are completed on time.
- Ensure timely issuance, review, and approval of Microbiology and environmental monitoring testing results.
What you bring
fda
excel
biology
bachelor's
gmp
quality
- Experience in an FDA-regulated environment, particularly in medical device, human tissue, or pharmaceutical manufacturing.
- Proficiency in Microsoft Excel.
- Knowledge in biology, human tissue, skin processing.
- Bachelor's Degree in a Life Science discipline or related field.
- Understanding of GMP compliance.
- Experience with tissue and cells.
- Knowledge of Quality System elements for CAPA, Non-Conforming Reports, and Deviations.
- Experience writing Standard Operating Procedures and Work Instructions.
- 0-2 years of relevant industry experience within Medical Device, Pharmaceutical, or Tissue commercial organization.
- Health Spending Account (HSA)
- Medical, dental & vision
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Critical Illness, Accident, and Hospital
- Short and long-term disability
- Transportation benefits
- Employee Assistance Program
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Time Off/Leave (PTO, Vacation or Sick Leave)
Information not given or found
Interview process
Information not given or found
Visa SponsorshipInformation not given or found
Security clearance- candidates must undergo background checks, including adherence to policies and procedures for fda, state osha, and iso compliance.
Company
Overview
$1.3B Annual Revenue
Revenue Figure
Generated annually through a network of technical and consulting services.
27,500+ Consultants
Consultants Network
Comprises a global network of expert professionals across industries.
- Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner.
- Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services.
- Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects.
- Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems.
- Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.
- We empower people to realize their full potential by providing opportunities to grow and learn.
- We build lasting relationships based on trust, integrity, and respect.
- We champion innovation, continuously seeking creative solutions.
- We are committed to delivering exceptional results for our clients and employees.
- We foster a collaborative environment where team members contribute to collective success.
2050
Target Year
The company has set a goal to achieve net-zero emissions by the year 2050.
- focused on reducing its carbon footprint and enhancing environmental sustainability.
- committed to making energy-efficient investments and improving operational practices for sustainability.
- focuses on reducing waste and increasing recycling in its operations.
- This company prioritizes creating an inclusive workplace where diverse perspectives are valued.
- The organization strives to increase gender diversity and empower women at all levels.
- The company regularly monitors and tracks progress on gender-related diversity goals.
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