Quality Control Data Reviewer

Rentschler Biopharma•Milford, MA

18h•Onsite

About The Position

As part of the Milford site’s Quality Control team, the Data Reviewer is responsible for the cGMP analytical data review and documentation generated during laboratory analysis in the quality control laboratory. Data review may consist of all/some of the following: Review and approval of QC test analytics; in process, release, stability, validation. Track, organize, prepare QC test results for product release. Review and approval of LIMS test results, labels and stage reports. Revise SOPs, Forms. Train employees on cGMP/GDP.

Requirements

B.S. in Chemistry, Biology, Chemical Engineering, or related biological sciences
3+ years in a cGMP analytical laboratory environment
HPLC , PA800, CS2500, SDS Page
LIMS, EMPOWER
cGMP experience
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
Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems

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 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
Assist in training of new hires and retraining of QC laboratory staff, as needed
Assist/mentor QC new hires on cGMP/GDP
Provide timely status updates to Management upon request
Performs other duties as assigned