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We got a new job details in Eurofins USA PSS Insourcing Solutions & they are Hiring Candidates for QC – CAPA Investigator
Company Name : Eurofins USA PSS Insourcing Solutions
Company Location : Bothell, WA
Job Position : QC – CAPA Investigator
Job Category : Jobs in California
Job Description :
Consider joining Eurofins Lancaster Laboratories where people are the most important element in our chemistry. Celebrating 50 years of service, Lancaster Laboratories is a leading contract lab providing testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide.
Eurofins Lancaster Laboratories, a nationally recognized laboratory, is searching for an experienced QC CAPA Reviewer to join our Professional Scientific Services group in Bothell, WA.
QC CAPA Reviewers responsibilities include, but are not limited to, the following:
Review cGMP manufacturing and QC investigations and bring them to a resolution
Perform review of root cause analysis on deviations; address comments from both internal and external stakeholders on the final report
Gather Data from various sources across the site, assess events for impact to product quality
Work closely with Departments, Quality Assurance, and support groups to ensure CAPAs are developed correctly
Initiate appropriate corrective action/preventative action (CAPA) to prevent deviation recurrence
Successfully execute the CAPA process and conduct follow-up to the implementation of actions deriving from investigations and reviews
Act as an area/department representative in deviation discussions, coordinating activity and proposals with functional area approvers for both deviations and CAPAs
Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward
Conflict resolution, problem solving in a cross-functional setting
Management of multiple projects and concurrent timelines
Ability to adhere to standard timelines, and escalate actions appropriately for resolution in a timely manner
Follow all cGMP guidelines and ensure all procedures are performed and documented per the applicable SOPS, policies, and regulatory guidelines
** REMOTE WORK AVAILABLE **
The ideal candidate would possess:
Proficiency with technical writing in cGMP or FDA regulated manufacturing environment
Ability to work in a fast paced environment and manage multiple projects and objectives for on-time event closure
Must work well on a team and be able to troubleshoot and problem solve in a cross-functional team setting
Must be proactive, action oriented, and adapt to change
Able to identify and flag risks in a timely manner to keep deliverables on track
Strong written and verbal communication skills
Ability to read and comprehend complex subjects
Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems
Ability to understand and apply GMP regulations as they relate to pharmaceutical manufacturing
BS in scientific discipline such as Biochemistry, Chemistry, Biology or related discipline
Minimum of 2+ years’ experience conducting/reviewing investigation and root cause analysis in a pharmaceutical or FDA/GMP environment required
Experience with GMP compliance in clinical/commercial manufacturing environment is required
Experience with quality management software (Mastercontrol, Trackwise, etc.) is preferred
Experience with asset management software (Blue Mountain, Maximo, etc) is preferred
Authorization to work in the United States indefinitely without restriction or sponsorship
What we offer:
Comprehensive medical coverage, with dental and vision options
Life and disability insurance
401(k) with company match
Paid holidays and vacation
Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.
We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.
We are looking forward to receiving your application including your expected salary and possible start date via our career website.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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