Analytical Services Data Reviewer

Abzena•Bristol, PA

About The Position

Abzena is seeking a highly skilled and detail-oriented Contractor to support our ANS team with documentation and data review activities related to routine QC tasks, including but not limited to Tech transfer, GMP release and stability testing. The ideal candidate will possess strong knowledge of compliance, technical expertise in separation-based analytical techniques (e.g., HPLC, GC, CE-SDS) including compendial testing and have a solid understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

Requirements

B.S. in Chemistry, Biology, Chemical Engineering, or related biological sciences
5+ years in a cGMP analytical laboratory environment
3+ years in Quality data analysis/review experience
Working knowledge of HPLC, UPLC, LC-MS
EMPOWER cGMP experience
Experience with stability testing
Strong familiarity with ICH guidelines, including but not limited to: ICH Q1A–Q1E (Stability), ICH Q2(R2) (Analytical Method Validation), ICH Q3A/B (Impurities in Drug Substances and Products)
Familiarity with analytical data trending, specification setting, and interpretation of development and stability data in alignment with regulatory and internal standards.

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