Job description

• Minimum of 1 year data review experience with minimum 5 yrs Lab Experience in pharmaceutical manufacturing environment.
• Minimum of 4-5 years of experience reading and interpreting

Role Summary

• The CQ Technical Data Reviewer reviews data from physical and dimensional testing of commodities, wet chemical techniques and instrumental analyses.
• Included in this review are visual evaluations, titrations, pH measurements, AA, HPLC, GC and UV/Vis among other analyses.
• In addition to data review, this individual could be responsible for preparing solutions, performing analyses, as well as recording and processing data in accordance with DEA, FDA, and ICH guidelines, as needed.

Role Responsibilities

• Functions as a dedicated data reviewer for the Chemical Quality Lab.
• Prioritizes data review and testing with guidance from Data Coordinator or supervisor.
• Assists in monitoring laboratory metrics associated with turnaround goals.
• As needed, prepares solutions required for testing, performs analysis, records data according to cGMPs, performs calculations and enters results into LIMS system.
• Provides support to assure lab safety and compliance -either through safe use of chemicals and/or the recognition of DEA, FDA, OSHA, and ICH compliance issues.

Basic Qualifications

• Bachelor of Science in Life Science (e.g. Chemistry, Biology, Microbiology, etc.)
• Minimum of 5 years of experience in a Quality Control or R&D laboratory and experience with a wide variety of analytical techniques (e.g., HPLC, GC, AA, UV-VIS, etc.) and biological techniques (e.g., BET, antibiotic potency, sterility, etc.).
• Knowledge of cGMPs and regulations outside of the US.
• Good communication, organization and computer skills are required.
• Knowledge of LIMS, Empower, and Microsoft Office programs is desired.

Required Qualifications

• Minimum of 1 year data review experience with minimum 5 yrs Lab Experience in pharmaceutical manufacturing environment.
• Minimum of 4-5 years of experience reading and interpreting chromatographic data.
• ICP-MS Experience Preferred

Required Technical Experience:

• HPLC basic experience (AA/ICP-MS)
• Empower3 Experience
• Chromatography Knowledge
• cGMP

Day 2 Day:

• HPLC
• GC
• AA/ICP-MS
• Data Review

Notes:

• True Experience is 3+ years
• Onsite - will need to adhere to return to site policy
• Assignments will be for 6-months with the possibility of extension up to 12-months

Job Type: Contract

Pay: $34.00 - $45.00 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Rocky Mount, NC: Reliably commute or planning to relocate before starting work (Required)

Experience:

• eading and interpreting chromatographic data: 4 years (Required)
• pharmaceutical: 3 years (Required)
• data reviewer: 4 years (Required)

Work Location: In person

seankuhnke.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, seankuhnke.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, seankuhnke.com is the ideal place to find your next job.