Description:
The Quality Compliance Specialist provides coordination and reporting that includes data collection/generation, data analysis and data review and interpretation. In addition, prepares summary findings to support change controls, planned deviations, new product launch compliance, as well as quality assurance trends related to various Quality Management processes.
Essential Functions:
- Reviews and approves (where applicable) respective data for the purpose of change, implementing, analyzing and reporting. The Associate collects / generates data for the purpose of analyzing and reporting. Additionally, supports preliminary investigations and prepares a summary of the findings to support NOIs, CAPAs, Complaints and other Quality related activities and projects. Regularly audits the tasks completed for reporting purposes and identification of any possible outstanding actions.
- Reviews all change controls, planned deviations, provide approvals (where applicable), issues tasks, monitor due dates for the associated tasks ,necessary follow-up activities are performed until all requested tasks have been completed and events are closed. Holds the responsibility of coordinating in preparation, review and approval process of NPLs (New Product Launches) within the required time frame. Maintain, track all commitments made to the agency as part of submissions
- Provides Senior Quality Management with timely data analysis and insights to support compliance to the systems and Propose adequate corrective actions and applicable improvements .
- Will collaborate with personnel from other functional areas to collect information and coordinate discussions to facilitate the resolution of quality issues/ concerns and distribute associated documentation as applicable.
- Act as a point of contact for assigned responsibilities towards external audits. Maintaining required concurrent documentation supporting regulatory audits.
- Regularly audits the Investigations and CAPA schedules for reporting purposes and identification of any possible outstanding actions.
- Prepare, review and present/submit all quality data with statistical approach. Act as a subject matter expert for electronic QMS.
- Notifies QM management of any activities or decisions that may impact the compliance of the sites that may lead to regulatory action. Prepares and/or ensures that extension documentation are in place for those which have been identified as unable to meet the scheduled due dates due to ongoing activities.
Additional Responsibilities:
- Assist with internal and regulatory audits as requested. Assist with analyzing, displaying and customizing data reports in formats such as scorecards and presentations on a bi-weekly, monthly and quarterly basis.
Education:
- Bachelors Degree (BA/BS) Related QA Field Experience - Required
Experience:
- 3 years or more in Related QA Field Experience
Specialized Knowledge:
- Organized, creative and the ability to communicate thoughts and ideas clearly. Able to present data and trends in a manner that is easily understood and is relatable.
Licenses:
Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.
The base salary for this position ranges from $80,000 to $95,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.
About UsAmneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
What We Do
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions. Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam. Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
