What are the responsibilities and job description for the AQA/Data Reviewer – Chemistry position at Orion Solutions LLC?
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 Rising 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 Prerequisites:
Excellent conceptualizing, analytical, and problem-solving skills Working knowledge of Microsoft Office/Excel/Access programs.
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
Effective written and oral communication skill; Strong organizational, planning, and communication skills; Demonstrates exceptional time management skills; Using logic and reasoning to identify solutions to problems; Ability to multi-task, set priorities, and meet strict deadlines; and Ability to lead, motivate, coach, and teach others.
Job Type: Full-time
Pay: $65,000.00 - $80,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
Ability to Relocate:
- Decatur, IL 62522: Relocate before starting work (Required)
Work Location: In person
Salary : $65,000 - $80,000