Data Reviewer I (QC)

About the role

The Quality Control Data Reviewer I supports the Stability & Reference Standard department and external customers. The primary responsibility is reviewing and approving primary analytical data according to cGMP guidelines.

Responsibilities

• Support technical data review of raw data generated for compendial testing and Curia In-house and client methodologies to ensure data accuracy and integrity.
• Trend stability data to ensure consistency with historical timepoints and no unexpected results.
• Verify calculations associated with Stability samples/Reference standards/Raw Materials/Intermediates testing are correctly done.
• Format and review Stability summary tables, Stability Protocols for accuracy and compliance with current Curia formats.
• Enter data into Stability summary tables. Perform tracking and trending of data as requested. Compile data and provide data summaries to management.
• Collaborate with lab personnel for data review per cGMP compliance, data integrity.
• Ensure all tests are per cGMP compliance and in compliance with the company’s standard operating procedures.
• Provide support on QA initiatives (Investigations, change controls etc.) when necessary.
• Review and approve test methods, SOPs, forms, and other documents as necessary.
• Coordinate testing performed at contract testing labs for stability samples etc.
• Attend internal and external training on related subjects, cGMP compliance and data integrity, new techniques and procedures.

Requirements

• Bachelor’s Degree in Chemistry or a related field.
• One year experience working in cGMP or GLP pharmaceutical industry environment.

Qualifications

• Must pass a background check.
• Must pass a drug screen.
• May be required to pass Occupational Health Screening.
• Knowledge, skills and abilities:
  • Chemical Hygiene training.
  • Working knowledge and understanding of various analytical instrumentation including but not limited to Gas Chromatography (GC), High-performance liquid chromatography (HPLC/UHPLC), ICP-MS, Infrared spectroscopy (IR), Differential scanning calorimeter (DSC), UV-Vis, Karl-Fischer auto titrator, Optical rotation, Dissolution, etc.
  • Understand and interpret complex analytical techniques such as Method Validation, Method Transfer, Method Verification, Stability testing methodologies.
  • Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
  • Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently.
  • Ability to meet deadlines and work under pressure with limited supervision.
  • Proficient in Microsoft Office Suite and instrument manufacture-based systems.
  • Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485.

Skills

• Sound judgement, critical thinking, and cGMP principles.

Benefits

• Generous benefit options (eligible first day of employment).
• Paid training, vacation and holidays (vacation accrual begins on first day of employment).
• Career advancement opportunities.
• Educational reimbursement.
• 401K program with matching contributions.
• Learning platform.

Pay

Pay range is determined based on education, experience, location and tenure.

Schedule

Flexible schedule to accommodate customer needs.