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Quality Control Analyst
Actalent
An engineering and sciences services and talent solutions firm connecting specialized experts with industry projects.
Perform biochemistry testing and documentation in a regulated medical device and diagnostics environment, supporting lab operations and continuous improvement.
16d ago
$40 - $40
Junior (1-3 years)
Full Time
Durham, NC
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
biochemistry testing
lims maintenance
equipment troubleshooting
validation protocols
hse compliance
team training
Document and review test results to ensure accuracy, completeness, and compliance with Good Documentation Practices (GDP).
Consistently utilize appropriate Personal Protective Equipment (PPE) for all laboratory activities.
Contribute to the revision and improvement of QC department SOPs.
Adhere to Health, Safety, and Environmental (HSE) requirements.
Provide support and input for Out of Specification (OOS) and laboratory investigation reports, including documentation of invalid test results.
Troubleshoot and resolve routine to moderately complex laboratory equipment issues.
Serve as a certified trainer for laboratory testing processes and instrument maintenance.
Enter data into the Laboratory Information Management System (LIMS) and assist with its maintenance and validation activities.
Maintain personal training records and ensure ongoing compliance with departmental processes.
Collaborate with other departments to execute validation protocols for laboratory equipment, software, and procedures.
Train and mentor teammates on biochemistry laboratory procedures and SOPs.
Participate in laboratory and organizational continuous improvement initiatives.
Prepare for and participate in regulatory, customer, and internal audits by maintaining logbooks, instrument calibration records, and ensuring laboratory cleanliness and compliance.
Maintain laboratory areas in accordance with 6S principles (Sort, Set in order, Shine, Standardize, Sustain, Safety) to ensure a clean, organized, and compliant workspace.
Conduct biochemistry testing of raw materials, intermediates, special test requests, and finished product samples following standard operating procedures (SOPs).
What you bring
regulated lab
attention to detail
communication
bachelor’s
lims
method validation
Experience in a regulated laboratory environment (FDA, GLP, GMP, CLIA, CAP) preferred.
Strong attention to detail and commitment to quality.
Effective communication and teamwork skills.
Bachelor’s degree (BS/BA) in Biology, Chemistry, Biochemistry, or a related discipline.
Familiarity with LIMS and laboratory documentation systems.
Ability to train and mentor others.
Method validation experience.
Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP).
Benefits
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)
Training + Development
Information not given or found
Interview process
Information not given or found
Visa Sponsorship
Information not given or found
Security clearance
comprehensive background checks, including criminal, education, and employment verification.
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