Quality Assurance Technical Data Reviewer
Posting ID: JP-002339687
Quality Assurance Technical Reviewer – Lenoir, NC
• Position: Quality Assurance Technical Reviewer (Microbiology)
• Placement: 12-month Contract-To-Hire
• Location: Lenoir, NC
• Schedule: Monday - Friday
• Shift: 1st
• Pay: $30 - 40/hr. Pay based upon experience.
• The Technical Data Reviewer is responsible for reviewing and approving technical documents such as method validation/verification protocols and reports, raw material testing, release and stability test data sheets and laboratory notebooks.
• MUST have a strong background (3+ years) in Microbiology
• Manufacturing Laboratory for Sterile Injectables and related products
• Multiple Sites within a couple miles of each other.
• Will be cross trained between the facilities.
• Will be in an office setting at a computer most of the time.
• Bachelor’s degree in Microbiology, Chemistry, or related scientific discipline with approximately 3 – 5 years of relevant experience in Microbiology or Analytical Chemistry. —OR—
o An Associate of Science Degree with approximately 6 – 8 years Analytical Chemistry or Microbiology experience required; preferably in QC, in the pharmaceutical industry.
• Must be excellent in attention to detail.
• Must have working knowledge of FDA regulations/guidance, good manufacturing practices (GMP), and ICH and USP/NF guidelines.
• Must be familiar with US Pharmacopeia.
• Must have working knowledge of Empower, Viktek, MODA.
• Strong ability to grasp software.
• Review and approve IQ, OQ, and PQ documents for all analytical instrumentation such as FTIR, HPLC, GC, AA, and UV/VIS, and have a scientific understanding of these techniques.
• Review documents that support incoming raw material and component release.
• Audit and ensure all activities are performed in compliance with cGLP/CGMP requirements.
• Review investigations on studies that have unusual results, and on out-of-trend and out-of-specification results.
• Write, review, and update standard operating procedures and department policies as needed.
• Review and be able to explain how to conduct Sterility and Endotoxin testing, particular matter. 3
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Kathleen LaMonaca