GMP QC Data Reviewer - Analytical Chemistry

Lever, Inc.; Bristol Township, Northern (Bucks County, KY); Hybrid; USD 55,000 - 110,000; Full time

Job summary

Abzena is seeking a highly skilled Contractor to support our ANS team with documentation and data review activities related to routine QC tasks, including tech transfer, GMP release and stability testing. The ideal candidate will have strong knowledge of GDP and GMP, cGMP analytical laboratories, and experience with HPLC, UPLC and LC-MS, enabling accurate data interpretation and timely product releases.

This role requires meticulous attention to detail, collaboration with QC and cross-functional

Qualifications

• 5+ years in a cGMP analytical laboratory environment.
• 3+ years in Quality data analysis/review experience.
• Working knowledge of HPLC, UPLC, LC-MS.
• Experience with stability testing and familiarity with ICH guidelines.
• Knowledge of GDP and GMP processes.
• Familiarity with analytical data trending and interpretation of development and stability data.

Responsibilities

• Review and approval of cGMP analytical data comparing results to internal and customer specifications, SOPs, and established standards to ensure accuracy and quality of data
• Works collaboratively with QC team members and cross functional teams for timely resolution of quality issues to achieve project goals
• Support Product Release activities ensuring timelines are met
• Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
• Identify and resolve issues with assistance from Data Review team
• Review of LIRs
• Support all data integrity initiatives and strive for right first time
• Make sound daily decisions about the quality of data based on biochemical knowledge and compliance background
• Revise, create SOPS and/or test forms as required
• Assists with metrics for trending and reporting as required, stability and QC analytical data
• Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
• Exceptional communication and interpersonal skills
• Strong knowledge of QC analytical equipment and software required
• Strong communications skills - written and verbal
• Able to prioritize workload to meet stringent timelines
• Provide timely status updates to Management upon request
• Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems
• Performs other duties as assigned

Skills

Attention to detail

Documentation accuracy

Communication skills

Problem solving

Education

B.S. in Chemistry, Biology, Chemical Engineering, or related biological sciences

Tools

HPLC

UPLC

LC-MS

EMPOWER

Job description

Abzena is seeking a highly skilled Contractor to support our ANS team with documentation and data review activities related to routine QC tasks, including tech transfer, GMP release and stability testing. The ideal candidate will have strong knowledge of GDP and GMP, cGMP analytical laboratories, and experience with HPLC, UPLC and LC-MS, enabling accurate data interpretation and timely product releases.

This role requires meticulous attention to detail, collaboration with QC and cross-functional