Nature and Scope

The position is responsible for reviewing Quality Control Laboratory data which may include raw material, in-process, and finished product release, instrument qualification protocol/report, stability program results and summaries, raw data related to the validation of pharmaceutical processes, and some tests performed in house are impurities, endotoxins, bioburden etc.

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.

• To ensure that all material/stability data is tested under strict cGMP conditions and documented as per the good documentation practices.
• Coordinate with quality control laboratory management and ensure timely release of material, instrument/stability data to meet the organization goals.
• Work with quality control management in resolving issues regarding test methods, specifications and take necessary steps for corrections.
• Provides quality review of laboratory raw data and reports including microbiological testing logbooks and environment monitoring.
• Perform and track trend reports for data review summaries and observations.
• Develop document review procedures including creation and revising SOP.
• Perform any other responsibilities assigned by the department manager.
• Will to be cross trained to review chemical or microbiology tests.
• 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.

• BS degree in Microbiology, Biology, Chemistry or equivalent combination of education and experience.
• 3-5 years of related quality control and quality assurance in the pharmaceutical industry.
• Must be familiar with cGMP/GLP practices for microbiology laboratory and ICH and FDA guidelines.
• Proven data review skills.
• Excellent verbal, written and organizational skills required combines with an aptitude for multi-tasking.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

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.

Expected Salary Range:

$78,100-$83,000

The salary range, displayed is the minimum and maximum annual salary range 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.

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.