Position Title: QA Data Reviewer, Chemistry

Location: Decatur, Illinois

Duration: Full Time

Education and Experience:

• Bachelor's Degree from a four-year accredited college or university with a Major in the Life Sciences (e.g., Chemistry, Biochemistry, or closely related field) or Pharmacy.
• Minimum of five years of demonstrated excellence in an industrial laboratory related to cGMP pharmaceutical manufacturing, specializing in sterile dosage forms.

Job Prerequisites:

• Ability to meet attendance standards.
• All employees are required to work a 40-hour week.
• At times it may be necessary to work additional hours to get the required tasks accomplished.
• Must have complete knowledge of current Good Manufacturing Practices, United States Pharmacopeia, Current Federal Register (CFR), and other applicable FDA regulations or guidelines.

Essential Duties & Responsibilities:

• Responsible for ensuring the integrity of all data and documentation reported from the Quality Control Laboratory.
• Experience in handling Agilent and Thermo HPLC and GC’s.
• Review the raw data of testing via the chromatography data acquisition system i.e. Chromeleon.
• Review various laboratory instrument's raw data and its audit trials such as UV, FTIR, KF, TOC analyzers, Headspace analyzers and Lab-X software for management of the off-line instrument data.
• Review all source data and associated documentation for accuracy and cGMP conformance.
• Review the applicable specifications for the raw material, finished product and stability studies.
• 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, etc.
• Assist in performing 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.

Additional Responsibilities:

• 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.

Job Type: Full-time

Pay: $60,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 5 years
• 6 years
• 7 years

Schedule:

• Day shift

Work setting:

• In-person

Experience:

• QA Data Reviewer: 5 years (Required)
• Sterile dosage: 2 years (Required)

Work Location: In person