Remote - QC CAPA Reviewer

Eurofins PSS Insourcing Solutions

Seattle Washington

United States

Scientific Research
(No Timezone Provided)

Company 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.

Job Description

** REMOTE WORK AVAILABLE **

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 **

Qualifications

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
Qualifications
  • 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
Additional Information

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.

Remote - QC CAPA Reviewer

Eurofins PSS Insourcing Solutions

Seattle Washington

United States

Scientific Research

(No Timezone Provided)

Company 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.

Job Description

** REMOTE WORK AVAILABLE **

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 **

Qualifications

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
Qualifications
  • 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
Additional Information

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.