- Reviews draft audit reports to identify and evaluate classification of audit observations and finalize into a comprehensive audit report.
- Prepares written audit documents and reports and ensures the quality and accuracy of all audit documentation.
- Identifies and communicates insufficiencies in audit responses.
- Ensures audit issues and extensions are initiated and processed.
- Writes and launches GMP audit CAPAs.
- Prepares and presents metrics to management.
- Assists with onboarding and maintaining GMP Auditing consultant records, assignments and audits.
- Reviews and processes additions and deletions to the GMP Auditing program.
- Supports review of the Audit Master List and audit schedules.
- Supports the internal and external auditors during the conduct of audits.
- Monitors training requirements to ensure department compliance.
- Liaises with audit clients to bring audits to closure.
- Evaluates change notifications received from external suppliers or partners and change controls for impact and ensures corresponding audit requests are submitted.
- Reviews, edits and/or approves controlled documents.
- Ensures written and departmental procedures, timelines and requirements are followed and met.
- Assists with department deviations.
- Assists in regulatory inspections as needed.
- Researches regulatory regulations and presents to GMP Auditing to ensure the department remains current with regulatory changes and trends.
This role may be for you if you: - Excel in a quality driven organization
- Have knowledge of 21CFR regulations, ICH guidelines, Eudralex, MHRA, EMA, USP, EP and ISO regulations
- Are organized and have an attention to detail
- Can prioritize multiple assignments and changing priorities
- Are able to learn and utilize computerized systems for daily performance of tasks To be considered for this role you must hold a Bachelors degree and the following amount of relevant experience for each level:
- Associate QA Specialist 0-2+ years
- QA Specialist 2+ years
- Sr QA Specialist 5+ years May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. #REGNQA Does this sound like you? Apply now to take your first steps toward living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.Salary Range (annually) $58, $124,300.00 -
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Description
We are currently looking to fill a Quality Assurance Specialist (GMP Auditing) position. This position will support the GMP Auditing department by handling GMP Auditing operational systems, coordinating consultant audit activities and continuous improvement initiatives.
In this role, a typical day might include the following:
