- Supports all Quality Assurance I roles as required
- Supports administrative function by:
- monitoring quality systems deadlines and reports to management pending and overdue activities
- assisting in Analytical Subcontractor documentation maintenance
- assisting with writing, reviewing, and approving Events, CAPA, OOS/OOT, and Change Control
- writing, reviewing, and conducting Quality System, cGMP, and GLP training as required
- Supports Data Reporting by:
- reviewing, approving, and releasing laboratory data
- reviewing, creating, and approving Certificates of Analysis
- reviewing and approving Cumulative Reports, Protocols, Technical Reports and Summaries
- reviewing and approving Methods
- Supports Document Control by:
- all Quality Assurance I roles
- maintaining all Master Lists
- maintaining Control of Specifications
- assisting with writing and approving internal documents
- Supports Equipment Control by:
- maintaining identification and calibration labels/cards
- reviewing and approving of preventative maintenance, verification, calibration, and qualification
- maintaining records in LIMS
- induction and decommissioning
- Supports Auditing by:
- performing Internal audits per Standard Operating Procedure
- supporting client and regulatory audits as needed
- Supports Stability as needed by:
- reviewing and approving Stability Protocols
- reviewing Stability Chamber Pull Schedules
- reviewing and approving Stability Chamber mapping
- monitoring and following up Stability Chamber excursions
- Supports Manufacturing as needed by:
- executing and reviewing batch records
- Quality Assurance inspection and release of cGMP materials
- Other functions as assigned
- 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
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Quality Assurance Associate II - Cary, United States - Eurofins
Description
Company DescriptionEurofins 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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
Required: a minimum of High School Diploma or Equivalent. Preferred Associate's Degree and/or certifications in laboratory/quality/regulatory
Required: Understanding of FDA requirements and Quality Systems
Preferred: Must have good administrative skills (Microsoft Office Suite, LIMS, QMS)
Preferred: 1 - 2 Years in a laboratory environment.
Preferred: 3+ years of GLP/GMP environment in laboratory operations or QA, or combination of both
Additional Information
Position is full-time, Monday - Friday 8:00am - 5:00pm . Candidates currently living within a commutable distance of Cary, NC are encouraged to apply.
