AQAData Reviewer Chemistry

POSITION DESCRIPTION

Position Title: QA Data Reviewer Chemistry Department: Quality urance

Reports To: Director of Quality urance Work Location: Decatur Illinois

Position Summary:

The primary responsibility of the data reviewer is to ensure all source data summary reports and doentation from the laboratory is of the highest quality ensuring data accuracy and integrity. The data reviewer reviews all ytical data for accuracy conformance to procedures and specifications and proper doentation in accordance with Rising SOPs and cGMPs. The igned individual also reviews raw data for use of appropriate ytical instrumentation use accuracy of calculations and conformance to all referenced ytical procedures and reviews the interpretation of the data for alignment with od 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 ysts and elevate if necessary to determine data disposition.

Essential Duties & Responsibilities:

Responsible for ensuring the integrity of all data and doentation reported from the Quality or R&D Laboratory Reviews all source data and ociated doentation for accuracy and cGMP conformance. Reviews all source data for conformance to applicable specifications Facilitates data or doentation corrections with ysts to ensure all records are complete and appropriate references are made. Ensures Investigations are igned to data or doentation as appropriate prior to data verification is signed off. Responsible for verifying all laboratory testing was conducted in accordance with SOPs as well as cGMPs and GLPs 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. ist in perform Quality urance audits on laboratory areas to ensure cGMP compliance ist in the investigation and review of deviation reports and OOS reports to ure complete compliant source data. ist in training and mentoring junior ysts 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 ist team members of varying capabilities and technical comprehension. Communicate regularly and effectively with all levels of the organization.

Education and Experience:

Bachelors degree in Life Sciences (e.g. Chemistry Biochemistry or closely related field) or Pharmacy from an accredited fouryear 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 ytical and problemsolving ss 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 s; Strong organizational planning and communication ss; Demonstrates exceptional time management ss; Using logic and reasoning to identify solutions to problems; Ability to multitask set priorities and meet strict deadlines; and Ability to lead motivate coach and teach others.

Disclaimer:

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 cirstances 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 jobrelated duties as required by his/her supervisor/manager. Requirements stated are minimum levels of knowledge ss 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 nondiscriminatory criteria. The ods of fulfilling requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. THIS DOENT DOES NOT CREATE AN EMPLOYMENT CONTRACT IMPLIED OR OTHERWISE. WE MAINTAIN AN AT WILL EMPLOYMENT.