Auditing Project Lead leads a group of auditors who identify risk, assess performance, prepare financial reports in various complex auditing projects. Schedules audit plans and builds audit criteria, ensures all auditing activities in accordance with organization's policies and standards. Being an Auditing Project Lead prepares auditing reports and suggestions to management. Provides oversight and guidance for auditors and may be responsible for training staff. Additionally, Auditing Project Lead ensures standard auditing practices are followed. Requires a bachelor's degree. May sometimes require the Certified Public Accountant (CPA)credential. Typically reports to a director or head of a unit/department. The Auditing Project Lead supervises a group of primarily para-professional level staffs. May also be a level above a supervisor within high volume administrative/ production environments. Makes day-to-day decisions within or for a group/small department. Has some authority for personnel actions. To be an Auditing Project Lead typically requires 3-5 years experience in the related area as an individual contributor. Thorough knowledge of functional area and department processes. (Copyright 2024 Salary.com)
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:
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.
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 Bachelor’s 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)
0 Auditing Project Lead jobs found in Troy, NY area