Eurofins Lancaster Laboratories

QA Specialist

Eurofins Lancaster Laboratories • $73K — $90K *
Fremont, CA 94536In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in a biological science or equivalent experience
  • Minimum 1 year of Quality Assurance experience
  • At least 2 years of relevant work experience
  • Ability to write and interpret standard operating procedures
  • Strong communication skills for internal and client interactions
  • Previous laboratory and cell culture experience preferred
  • Experience in a GxP/regulated environment preferred

Responsibilities

  • Maintain the Quality Management System
  • Perform document control activities
  • Support writing, reviewing, and revising SOPs and business documents
  • Ensure documents comply with internal procedures
  • Create and update training files and provide training sessions
  • Conduct internal audits for compliance
  • Act as a subject matter expert in specific quality systems

Benefits

  • Comprehensive medical coverage
  • Dental and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays
Full Job Description
Job Description

The Quality Assurance Specialist is responsible, as a member of the Quality Assurance Unit (QAU), for implementing and maintaining the quality management system. The QA Specialist will assure that the quality assurance programs are maintained in accordance to pertinent regulatory requirements and internal SOPs in the performance of the duties of this position.

Here's what you'll do:
  • Maintain the Quality Management system
  • Perform document control activities.
  • Provide quality support in writing, reviewing, revising, and maintaining standard operating procedures (SOPs), forms, presentations, and other business documents.
  • Assure documents capture the current process, provide sufficient detail to perform the process, and comply with internal procedures for generating documents.
  • Support the training program, such as creating training files and ensuring that they are updated and current as appropriate.
  • Provide training sessions.
  • Host meetings and/or scribe meeting minutes.
  • Follow up on CAPA and Change Control systems, as appropriate.
  • Perform internal audits to ensure compliance is maintained within the organization. May provide audit reports to the applicable audited function/area management.
  • Cooperate in the preparation of study files prior to and during all client audits and regulatory inspections.
  • Attend meetings and participate on multi-disciplinary teams, as required, to provide routine status updates related to their functional area and/or to provide quality guidance.
  • Become a subject matter expert (SME) in a particular quality system (i.e. documentation, supplier quality, other) depending on experience, skill set, and business needs.
  • Conduct QA reviews of study data generated when required.
  • Generate QA statements for study reports when required


Qualifications

The ideal candidate:
  • Ability to follow instructions and deliver complete and accurate results.
  • Ability to perform tasks independently, and as team player.
  • Ability to read and understand common Quality Assurance processes.
  • Ability to write and interpret documents such as standard operating procedures.
  • Ability to speak effectively and professionally with internal colleagues as well as with clients when needed.
  • Ability to construct, communicate, and interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Bachelor's Degree in a biological science related field, or equivalent work background
  • Minimum 1 year QA experience
  • Minimum 2 years work experience
  • Previous laboratory experience preferred.
  • Previous experience with cell culture preferred.
  • Previous experience within GxP/regulated environment preferred.


Additional Information

The position is full-time, Monday-Friday, 8 a.m.- 5 p.m., with overtime as needed. Candidates within a commutable distance of Fremont, CA are encouraged to apply.

Salary range: $73,000 - $90,000/yr.
  • 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

About Eurofins Lancaster Laboratories

Eurofins Lancaster Laboratories is a leading contract research organization (CRO) providing analytical, research and testing services to clients in the pharmaceutical, biopharmaceutical, biotechnology, crop protection, chemical, food, environmental and consumer products industries. The company was founded in 1961 and has grown to become one of the largest CROs in the world, with over 50 locations in 20 countries. Eurofins Lancaster Laboratories is part of the Eurofins Scientific Group, a global leader in bioanalytical testing and laboratory services. The company's services include method development and validation, stability testing, quality control testing, and regulatory compliance support.
Learn more about Eurofins Lancaster Laboratories
Size
12,000 employees
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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