Quality Control Data Reviewer

Job Title: Quality Control Data Reviewer

Location: 3025 market street Philadelphia PA 19104(Onsite)

Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed

The Quality Control (QC) team is seeking a QC Data Reviewer. This position will be directly responsible for performing the review and approval of all GMP data generated by QC and contract organizations, including paper and electronic data. Under the general guidance of the QC Stability and System Lead, s/he will work independently to ensure data integrity and all GMP/GDP and regulatory requirements are met.

The responsibilities include but not limited to:

● Review and approve GMP data, including paper and electronic data

● Review audit trails and instrument logbooks

● Hire, train, and supervise data reviewers

● Develop and maintain data integrity program

● Author and review SOPs, manage non-conformance events as needed

● Develop and maintain department metrics on turnaround and right first time Supporting QC during audits and regulatory inspections

Responsibilities

● Review and approve GMP data, including paper and electronic data

● Review/approve paper and electronic data.

● Review audit trails.

● Develop and maintain right first-time metrics.

● Assist on instrument assessment.

● Manage the comprehensive and timely data review of all GMP data generated by QC and CTL.

● Develop and maintain data integrity program.

● Author and review SOPs, manage non-conformance events as needed.

● Assist in additional sample management activities

Education and Experience Requirements

● BS or MS degree on biological, chemical sciences, or related discipline, is required.

● 5 years for BS, 2 years for MS, 1 years for PhD, of related experience in the Pharmaceutical/Biotech industry working in a GMP/regulated environment.

● Strong scientific knowledge and demonstrated analytical background are required.

● Should be familiar with the following assays: SDS-PAGE, Western Blot, SEC, CE-SDS, cell-based assay, qPCR, ddPCR, ELISAs, DLS, compendial assays.

● Excellent understanding to data integrity principle is required.

● Proven experience in analytical instrument is preferred.

● Experience in reviewing audit trail is preferred.

● Experience in lab investigation and deviation is preferred.

● Excellent communication skill is required

Key Skills, Abilities, and Competencies

● Possess great interpersonal and communication skills

● Possess excellent skills on prioritizing and time management

● Highly motivated and detail oriented with good organizational skills

● Possess the ability to multitask and work independently or in a team environment with minimum supervision

● Proven analytical aptitude, critical thinking skills and ability to apply key concepts

Complexity and Problem Solving

● Develop solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.

● Ability to build productive working relationships internally and externally.

● Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

● Exercises judgment within defined procedures and practices to determine appropriate action.

● Works under minimum supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.

Internal and External Contacts

● Frequent internal and external contacts. Represents organization on specific projects.

● This position works closely with QC Analysts, QC Management, and Quality Assurance to assure GMP data reviewed/reported in timely manner.

● This position advises management on matters related to data integrity and department metrics.

Other Job Requirements

● Position is an office-based role with some lab-based activities and therefore requires the candidate to be onsite majority (? 90 %) of time.

● May need some weekend work and/or late shift work.