Analytical QA Data Reviewer

Position Summary:

The primary responsibility of the data reviewer is to ensure all source data, summary reports and documentation from the laboratory is of the highest quality, ensuring data accuracy and integrity. The data reviewer reviews all analytical data for accuracy, conformance to procedures and specifications, and proper documentation in accordance with company SOPs and cGMPs. The assigned individual also reviews raw data, for use of appropriate analytical instrumentation use, accuracy of calculations and conformance to all referenced analytical procedures and reviews the interpretation of the data for alignment with method validation reports and scientific legitimacy. The data reviewer reviews all electronic data audit trails in detail to ensure data integrity is not compromised in any way and ensures all signatures, electronic or written are intact prior to the release of laboratory data. The reviewer is responsible to discuss data interpretation and questions with individual analysts and elevate, if necessary, to determine data disposition.

Essential Duties & Responsibilities:

Responsible for ensuring the integrity of all data and documentation reported from the Quality or R&D Laboratory Reviews all source data and associated documentation for accuracy and cGMP conformance. Reviews all source data for conformance to applicable specifications Facilitates data or documentation corrections with analysts to ensure all records are complete and appropriate references are made. Ensures Investigations are assigned to data or documentation, as appropriate prior to data verification is signed off. Responsible for verifying all laboratory testing was conducted in accordance with SOP's as well as cGMP's and GLP's Review of Laboratory notebooks for completeness, and archival, as appropriate. Interacts closely with Quality Management and all team members to identify and aid in the implementation of data security, integrity or efficiency improvements Understands testing and procedures within Quality testing. Performs work in accordance with general and specific safety precautions Interacts routinely with departments such as Production, QA, RA, R&D, Validation Works on multiple projects in a concurrent manner on a routine basis. Assist in perform Quality Assurance audits on laboratory areas to ensure cGMP compliance Assist in the investigation and review of deviation reports and OOS reports to assure complete compliant source data. Assist in training and mentoring junior analysts on the interpretation of data and use of electronic data systems. Demonstrate a consistent high level integrity, professional discipline and dedication to quality compliance and improvement. Exhibit a high level of technical aptitude and maintain an approachable demeanor to assist team members of varying capabilities and technical comprehension. Communicate regularly and effectively with all levels of the organization.

Education and Experience:

Bachelor's degree in Life Sciences (e.g. Chemistry, Biochemistry, or closely related field) or Pharmacy from an accredited four-year college or university. 6 or more years of demonstrated excellence in an industrial laboratory related to pharmaceutical manufacturing, specializing in sterile dosage forms.

Job Type: Full-time

Pay: $70,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to Relocate:

• Decatur, IL 62521: Relocate before starting work (Required)

Work Location: In person

Salary : $70,000 - $80,000