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Responsible for executing Corrective and Preventive Actions (CAPAs) and effectiveness checks in compliance with SOPs and cGMP requirements. The role involves collaborating cross-functionally to support regulatory audits, customer non-compliance reports, and the Quality Council process.
Requires a Bachelor's degree in science or engineering and at least 5 years of Quality Assurance experience in a regulated environment. Candidates must have strong knowledge of FDA regulations and proven experience in CAPA writing and risk management.
The QA Senior Specialist - CAPA is responsible for ensuring that Corrective and Preventive Actions (CAPAs) and associated effectiveness checks are executed in compliance with company SOPs, internal policies, and applicable cGMP requirements. This role also supports the customer SNCR process, regulatory audit activities, and the Quality Council process. This is a cross-functional position that collaborates with all departments across American Regent. The incumbent will actively participate in planning, implementing, and maintaining quality systems to meet or exceed the company’s quality standards and regulatory expectations.
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Coordinate specific departmental activities with the goal of maximizing efficiency of management control systems, programs, policies, work methods and procedures. Collaborate with QA staff, colleagues, and leadership to ensure that goals and objectives are accomplished in a timely manner.
Interact and maintain relationships with colleagues, investigators, CAPA owners and staff in facilitating department objectives and ensuring positive working interactions.
Provide detailed attention to carry out activities in support of the QA Department with interrelated activities of other programs, departments or staff and communicate within the appropriate timeframe.
Work independently and recognize daily needs to be met with minimal supervision while delivering timely results.
Effectively manage multiple tasks.
Ensure any Corrective / Preventative Actions and Effectiveness Checks associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated, written and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify issues, evaluate metrics and provide support for internal audits under the direction of the QA Supervisor.
Ensure CAPA and Effectiveness timelines are maintained through inter-department communication with escalations as necessary.
Facilitate meetings to drive aging CAPAs and Effectiveness Checks to completion.
Review of Quality Systems data and metrics for trends within assigned area of support and report to QA Manager.
Confirm the completeness, accuracy and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality.
Complete monthly metrics for CAPA and Effectiveness Checks.
Additional Quality System Support
Support inspection readiness for regulatory inspections and internal or third-party audits.
Provide support for customer Non-Compliance reports received (SNCRs).
Support Quality Council and Management Review meetings, including preparation and follow-up activities.
Participate in cross-functional training with the QA Deviations team as needed.
Participate in continuous improvement initiatives to enhance the Quality System.
Identify and participate in initiatives to continuously improve the Quality System.
Represent the QA group in continuous improvement committees or working groups.
Perform any other tasks/duties as assigned by management.
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 discipline required.
5+ years of Quality Assurance experience in a regulated environment, required.
Knowledge of applicable FDA regulations, and experience in interpreting and applying to the organization, required.
Strong analytical, critical thinking, and problem-solving skills.
Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. Ability to effectively present information to top management, employees, or customers.
Demonstrate experience in CAPA writing, documenting issues, impact assessment, and risk management.
Understanding of how the pharmaceutical process pathway works, specifically how each of the various disciplines interact with each other.
Exceptional organizational and time management skills with the ability to effectively manage multiple tasks.
Detail-oriented with the ability to work independently and collaboratively in a team environment.
Computer skills to include Microsoft Word, Excel, PowerPoint, preferred.
$80,000 - $95,000
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
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 jrossini@americanregent.com 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 https://careers.americanregent.com/ 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.
American Regent, Inc, a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide. American Regent continues to position its business for sustainable growth, with significant investments in the modernization and expansion of our U.S. manufacturing sites. These enhancements are expected to strengthen our business and represents our commitment to the ongoing success of our company and its employees. Supporting patient health is our guiding principle and our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of brand and generic specialty injectables.
Offices: 5 Ramsey Rd, Shirley, New York 11967, US · 6610 New Albany Rd E, New Albany, Ohio 43054, US · 536 Vanguard Way, Brea, California 92821, US
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