QA Specialist, Aseptic Manufacturing Oversight

Nature and Scope

The QA Specialist, Aseptic Manufacturing Oversight ensures that American Regent operates in compliance with all applicable procedures and regulations. This role provides real-time quality oversight in aseptic manufacturing areas to ensure operations meet GMP, regulatory, and site quality standards. This role delivers immediate support, promotes a strong quality culture, and partners with operations and quality staff to achieve production goals while maintaining compliance. Responsibilities include proactive issue identification, timely decision support, and reinforcing high standards of quality and compliance. The role is responsible for providing oversight for Aseptic Processing Area (APA) in relation to aseptic practices and behaviors, including direct video monitoring of aseptic manufacturing. The role also supports training, metrics, trending and investigations related to aseptic behaviors and practices.

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.

• Perform in person APA oversight as assigned. Requires gown qualification maintenance.

• Perform APA video review, including but not limited to, gowning, APA cleaning, filling room set-up, filling activities, and environmental monitoring. Video review may be required to be performed live or retrospectively.

• Provide immediate GMP and aseptic behavior guidance to operators and supervisors.

• Identify and escalate major and critical observations identified during video review to shop-floor immediately in case of live video review, and to supervision/management for retrospective video review.

• Evaluate and appropriately categorize observations from video review as per procedure and/or protocol.

• Document video review performance and observations as per procedure and/or protocol.

• Assist with video review of Environmental Monitoring and Personnel Monitoring events, as assigned.

• Assist with trending and tracking of video review observations to aid in CAPA development.

• Assist with development and delivering training related to aseptic manufacturing behaviors and practices.

• Review and approval of deviation investigations and CAPAs.

• Actively Participate in cross-functional project teams.

• Collaborate with colleagues to achieve desired outcomes.

• Make recommendations for improvements to procedure and processes.

• Keep informed about current good industry practices and recommend areas of improvement.

• Consistently perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.

• Communicate with tact and consideration for feedback to remain constructive.

• 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 a Science or Engineering field, required. Equivalent years of experience to be considered.

• 2-5 years’ experience within the pharmaceutical industry including aseptic manufacturing required.

• Demonstrate ability to become and remain gown qualified for APA presence, required.

• Strong knowledge of appropriate Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with the ability to assess compliance risks.

• Demonstrate ability to perform detail-oriented work with a high degree of accuracy.

• Excellent verbal, written, and interpersonal communication skills.

• Effective time management and collaboration skills.

• Strong organizational skills, planning skills and must work effectively within teams.

• Ability to resolve conflicts and disagreements on regulatory compliance issues.

Physical Environment and Requirements

• May have to wear protective clothing in the laboratories and manufacturing areas for access as required for safety and product controls.

Expected Salary Range:

$70,100 - $80,000

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.

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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· 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.

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