QA Validation Specialist (Document Review)
Regeneron
This job is no longer accepting applications
See open jobs at Regeneron.See open jobs similar to "QA Validation Specialist (Document Review)" Advanced Energy Group, LLC.The QA Validation Oversight department is hiring! This team leads all aspects of documentation for validation areas across the business, including QC, Process Sciences, operations, CSV, gene and cell therapy, tech transfers and transfer of products.
As a QA Validation Specialist-Document Review, a typical day might include the following:
Reviewing and providing quality oversight of results of validation activities, including, but not limited to: Shipping, Equipment, Computerized Systems, QC methods and process.
Generating, implementing and/or reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
Reviewing the results of testing and determining the acceptability of results against pre-determined criteria.
Investigating and troubleshooting problems and providing recommendations for changes and/or improvements.
Reviewing, editing and approving deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation
Coordinating with other departments or outside contractors/vendors to complete validation tasks.
May supervise, provide direction and assign work to Validation Specialists and/or contingent workers to meet goals and timelines.
This role may be for you if you:
Maintain integrity and honesty at all times
Can work independently or as part of a team
Communicate with transparency
Continuously drive to improve processes for improved performance
Demonstrate supportive behavior at all times
Have basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint)
Gather and organize information while meeting commitments on time
Perform well-defined tasks
Have effective time management skills
To be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences and:
Associate QA Validation Specialist: 0-2 years of relevant experience
QA Validation Specialist: 2+ years of relevant experience
Sr. QA Validation Specialist: 5+ years of relevant experience
May substitute proven experience for education requirement
A background in Quality Control, Process Sciences and/or manufacturing/lab equipment in a pharmaceutical setting is preferred.
#REGNQA
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
This job is no longer accepting applications
See open jobs at Regeneron.See open jobs similar to "QA Validation Specialist (Document Review)" Advanced Energy Group, LLC.