Quality Assurance Specialist II

Nature and Scope

Support the planning creation implementation and control of quality functions for ARI to ensure product reliability quality and efficacy compliance to applicable state and federal regulations Current Good Manufacturing Practices (cGMPs) and internal standards for manufacturing materials and finished products.

Essential Duties and Responsibilities

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

• Perform Deviation QA initial evaluation and review and close deviations.
• Support CAPA system initiation review approval and implementation.
• Track status followup and ensure timely closure of Deviation investigations and CAPAs.
• Oversee CAPA effectiveness and verification. Assist in implementation of new CAPAs.
• Provide Quality operation support to ensure no production interruption.
• Support manufacturing on shop floor.
• Perform line clearance and batch record review.
• Perform aseptic processing audits; perform quality oversights of facilities process and personnel to ensure GMP compliance.
• Perform and ensure timely completion of batch record review and product disposition.
• Review quality documents including logbooks qualification protocols and reports.
• Review approve and support change control.
• 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.

• Bachelors degree required preferably in a scientific discipline or equivalent combination of education and experience.

• 5 Yrs. experience within the quality function in the pharmaceutical industry with specific experience in GMP FDA and ICH regulated environment.

• Have experience with writing and reviewing deviation investigation and CAPA.
• Have experience with aseptic process.
• Have experience with batch record review and supporting manufacturing on shop floor.
• Thorough knowledge of GMPs GLPs and pharmaceutical products.
• Expertise with writing editing or reviewing documents such as SOPs work instructions batch records guidelines etc.
• 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.

• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

• Employees must maintain a cleanshaven appearance each working shift to wear tightfitting respirators properly.
• Employee must be able to occasionally lift and/or move up to 25 pounds.
• This job operates in a professional office environment and manufacturing floor.
• This role routinely uses standard office equipment such as computers phones photocopiers filing cabinets and fax machines.
• A large portion of the work will be performed in the plant where the noise may be moderate.
• Will require sitting walking crouching standing and cleanroom full gowning.

Expected Salary Range:

$

The salary range 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 candidates 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.

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