QA Data Reviewer, Chemistry

Position Title: QA Data Reviewer, Chemistry Department: Quality Assurance
Work Location: Decatur, Illinois

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 and 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.
• Provide support during internal and external audits related to regulatory, pre-inspection approval, and corporate 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.
• Experienced in the use of e-learning content applications.
• 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.

• The list under Essential Functions and Additional Responsibilities is not exhaustive, but merely the most accurate list for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. This position description in no way states or implies that the responsibilities and tasks are the only responsibilities and tasks to be performed by the employee occupying this position. She/He will be required to follow any other instructions and to perform any other job-related duties as required by his/her supervisor/manager. Requirements stated are minimum levels of knowledge, skills and/or abilities to qualify for this position. To perform the duties and responsibilities of this position successfully, employee will possess the abilities and aptitudes to perform each task proficiently. Employment decisions, including promotions, transfers and others, are based on meeting all requirements and on organizational needs, the employee being in good standing (including lack of disciplinary actions), meeting all applicable performance standards and other non-discriminatory criteria. The methods of fulfilling requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.

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