QA Specialist

3 weeks ago

San Juan, United States Eurofins Full time
The work we do at Eurofins matters, and so do our employees.
At Eurofins, we put a focus on your professional growth.
We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up.
We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable.
From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services.
It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
If you're looking for a rewarding career, a place to call home, apply with us today
POSITION SUMMARY:

The QA Specialist, Document Control is responsible for document management system use and end user support.
The role manages document workflows within the electronic document management system, provides administrative approval for document promotion workflows, and provides inputs to document standards including formatting requirements.
This position also aids with controlled document issuance, reconciliation and executed document archival.
This role is responsible for logbook issuance, executed batch record issuance, and coordinating client/ third-party approval for master and executed batch records.
This role is responsible for managing local document library, archiving records in accordance with the Controlled Index of Company Records (CICR) standards, and recall for executed records to support internal, corporate, third-party, and regulatory audits.
POSITION RESPONSIBILITIES:

Issue and Manage documents through various workflows in the electronic document management system
Ensure documents meet procedural requirements for formatting, training assignments, properties, and related meta-data
Issue/ recall official document prints including business continuity folders for the site
Manage physical document library, prepare records for archive per CICR requirements, and retrieve records as required
Deliver site-level end user support and training for the global electronic document management system
Serve as document author and SME for document management processes
Ensure Master Batch Records, Specifications, Laboratory Methods, Protocols, and similar cGMP documentation receive client/ third-party approval prior to implementation.
Complete logbook and executed batch record issuance activities.
Interface with cross-functional teams such as Operations, Training, Quality Management, Engineering, Maintenance, Supply Chain, etc.
for Document Control functions supporting the site.
Qualifications BASIC MINIMUM QUALIFICATIONS:

High School or Associate's degree with 3-5 years relevant experience or Bachelor's degree with 2-3 years relevant experience or Master's degree with 1-2 years relevant experience.
•
Proficient in Microsoft Office software (Word, Excel, PowerPoint)
PREFERRED QUALIFICATIONS:

Experience executing transactions in a Document Management System
Experience conducting classroom and on-the-job training sessions
Experience with proofreading/ formatting documents
Additional Information Position is Full Time, Monday-Friday, 8:
00am-5:
00pm with overtime and weekends as required .
Candidates currently living within a commutable distance of Sanford , NC are encouraged to apply.
Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.
Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Eligibility for potential yearly Bonus & Merit-Based Pay Increases
Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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