QA Batch Record Review 1

Nature and Scope

This position is a member of the Quality Assurance (QA) Batch Record Review Group.  The QA Batch Record Reviewer I is responsible for providing the Quality Assurance review associated with the manufacture of safe, pure, effective, and sterile pharmaceuticals in accordance with company Standard Operating Procedures (SOPs), policies and current Good Manufacturing Practices (cGMPs).  The Batch Record Review group provides support to other departments as needed and is critical in maintaining product release schedules and meeting company goals. The quality review of the batch record includes the correction and approval of batch record documentation. The position requires collaborating with multiple departments regarding metrics, exception reporting and knowledge of regulatory documents and cGMPs.  This position includes travel between the American Regent facilities.

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.

·       Performs a critical review of the executed batch record documentation.

·       Work with personnel to resolve errors and/or discrepancies.

·       Assures all errors and corrections are resolved according to SOP requirements.  

·       Enter data into applicable spreadsheets/databases.

·       Update metric reports for trending.

·       Ensure all work is performed and documented in accordance with existing Company policies and procedures, in accordance with Code of Federal Regulations, and mutually recognized agreements with international regulatory bodies as well as and health and safety requirements.

·       Submit error free batch records for product release.

·       Oversee creation, assignment and closure of logbooks as requested by site-wide personnel. (Shirley only)

·       Assign and maintain Lot Number Assignment for product lots to support weekly production filling activities. (Shirley only)

·       Assemble, issue and check batch records for manufacturing process. (Shirley only)

·       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.

·       High School Diploma or GED equivalent required. Associate degree preferred.

·       Minimum one year of prior work experience and/or transferable skills is required.

·       High attention to detail, basic problem-solving abilities, and clear written communication.

·       Basic understanding of cGMP regulations, Good Documentation Practices (GDP), and pharmaceutical manufacturing workflows.

·       Skills in Microsoft Word and Excel and Electronic Management Systems are required.

·       Ability to take feedback constructively and function in a team-oriented work environment.

·       Ability to work overtime as needed.

Physical Environment and Requirements

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

Expected hourly range:

$21.06 - $24.00

The hourly range displayed is the minimum and maximum hourly rate 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

Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:

·All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.

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

·If you are unsure about the legitimacy of a message, contact John Rossini at [email protected]  before responding.

·We never request payment, bank information, or personal financial details during our offer process.

Your security is important to us, and we encourage you to stay vigilant when job searching.

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