QA Data Reviewer, Chemistry

4 weeks ago

Decatur, United States RISING PHARMA HOLDINGS INC Full time
Job DescriptionJob Description

Position Title: QA Data Reviewer, Chemistry

Department: Quality Assurance

Experience: 7-15 Years

Location: Decatur, Illinois

Term: Full Time

Position Summary:

Ensure all source data, summary reports and documentation from the laboratory is of the highest quality, ensuring data accuracy and integrity. Reviews all analytical data for accuracy, conformance to procedures and specifications, and proper documentation in accordance with Rising SOPs and cGMPs. Also, review 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. 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. 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 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.

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.

Physical Demands, Mental Requirements, and Work Environment:

  • While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear.

  • The employee is required to use hands to finger, handle, or feel.

  • Specific vision abilities required by this job include close vision for written work and PC use.

Mental Requirements

  • Ability to write, read, and apply technical scientific writing, procedures, and quality policies.

  • Ability to work independently in an efficient and detail-oriented manner.

  • Ability to work in an independent manner, as well as a group environment.

  • Ability to apply deductive reasoning and analytical thought to understand complicated issues.

  • Ability to receive instructions and follow work rules and company policies.

  • Ability to follow safety and security practices.

  • Ability to maintain confidentiality of certain information.

Required Citizenship / Work Permit / Visa Status*:

  • USA Citizen/Green Card Holder/H1 Transfer/EAD

Must Haves:

  • 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.

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