QA Specialist

Nature and Scope
Ensures quality system compliance with GMPs procedures and documentation within the company and in keeping with the internal audit program. Interacts with all levels of the organization and maintains on-going dialogue with management.

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.

• Under supervision assist with documentation for the closure of investigations.

• Assist in gathering data for reports metrics Annual Product reviews Quarterly reports and external requests.

• Scheduling departmental meetings maintaining meeting minutes and attendance.

• Maintain departmental records and files (both electronic and manual).

• Participate in cross-functional project teams as required.

• Support coordinate and assist with regulatory agency audit tasks as required in support of regulatory agency inspections.

• Support and maintain quality programs policies processes procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP).

• Keep training curriculum current.

• Ensure all work is performed and documented in accordance with existing company policies and procedures.

• 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 or GED diploma required. Associates degree or equivalent years of experience preferred.

• Experience working in a Quality role within a cGMP manufacturing environment required.

• Knowledge and understanding of quality assurance principles controls and interactions between Quality Systems; FDA guidance ICH PIC/S etc.

• Strong attention to detail adherence to SOPs.

• Ability to work effectively in a collaborative environment.

• Ability to effectively work under dynamic constraints with success in managing multiple activities concurrently and producing outstanding results.

• Strong organizational interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues.

• PC Skills Required (MS Word Excel).

• Ability to work overtime as needed.

Physical Environment and Requirements

• Physically able to wear cleanroom/protective gowning and equipment including but not limited to gowning goggles face shields and protective gloves. PPE is essential for the health and safety of employees.

Expected Salary Range:

$70100 - $85000

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 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.

• FMLA poster: Your Rights: Know Your Rights: Workplace discrimination is illegal ()

• Employee Polygraph Protection Act: Were 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 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 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.

  American Regent Inc. endeavors to make 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 .