QA Data/Document Review Associate

Nature and Scope

To provide a comprehensive Quality compliance review of cGMP/GxP Analytical Chemistry data and results for raw materials, in-process and finished product release, stability program results and summaries, and raw data related to the Validation of pharmaceutical processes. To facilitate corrections and clarifications to the reviewed data and provide a final approval of the records.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Provides quality assurance review of Chemistry laboratory raw data and reports including analytical worksheets, test summaries and stability summaries.

• Participates in identifying quality process improvements to increase efficiency and performance of systems, operations and personnel relating to the QA Data Review process.

• Writes and revises SOP's and other GMP documentation as needed.

• Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, compendia, and all applicable FDA Guidance document requirements and other company requirements.

• Participates in other Quality System activities with other team members as needed.

• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelor's degree in the Physical Sciences (preferably Chemistry), Mathematics or related field, or Associate's degree in Science with experience in data review required.

• Minimum 2 years experience in a chemical testing, laboratory setting with a working knowledge of wet chemistry (USP/EP) and instrumental analysis techniques (HPLC, UV-Vis, FTIR), or at least 1 year of Chemistry data review experience.

• Demonstrates extreme attention to detail to achieve quality results.

• Ability to perform multiple activities at the same time and produce outstanding results to meet required deadlines.

• Exercises a willingness to learn and take on added responsibilities as needed.

• Excellent organizational, interpersonal and communication skills (oral and written) to work in a team environment.

• Ability to work overtime as needed.

Physical Environment and Requirements

• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.

• Employee must be able to occasionally lift and/or move up to 25 pounds.

Expected Hourly Rate:

$38.41-$41.55

The hourly rate displayed is the minimum and maximum hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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• Our recruiting process includes multiple in person and/or video interviews and assessments.
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