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QA Compliance Associate

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Date: Apr 8, 2021

Location: San Diego, CA, US

Company: Wacker Chemie AG

 

 

 

Our world needs ideas! As one of the world’s most research-intensive chemical companies, Wacker has been developing leading solutions for numerous sectors – from construction to photovoltaics and cosmetics to rubber – for over 100 years. We have a global presence with production sites on three continents and 13,800 employees from 70 nations.

 

Wacker Biotech, as part of Wacker, is a leading global biotechnology organization specializing in the production of biopharmaceuticals. The company has outstanding technologies for the rapid, efficient and thus cost-effective production of therapeutic proteins for clinical and commercial supply. Currently it is the biggest dedicated microbial Contract Development & Manufacturing Organization (CDMO) in the world. Its four dedicated and fast-growing production sites are currently based in Germany (Halle and Jena), The Netherlands (Amsterdam) and The United States (San Diego, CA).

 

Our regional presence in the U.S. is focused on GMP-compliant manufacturing of plasmid DNA products up to 500L. The team has extensive experience up to phase III clinical supply and successfully released more than 100 GMP batches for advanced therapy applications. 

 

At our San Diego site, we are currently looking for a  QA Compliance Associate.

Job Responsibilities

 

This position is responsible for working closely with Wacker Biotech US Management and Departmental staff in support of the Quality Management System and ensure compliance with Wacker Biotech US quality expectations and cGMP's

  • Working with the Wacker Biotech US Quality Vendor program to perform audits of Contract Organizations (CMO/CRO/CTL) to ensure compliance with Wacker Biotech US quality expectations and cGMP's.
  • Maintain and improve a quality system for internal and external auditing.
  • Maintain and improve a quality system for training.
  • Maintain and improve the QA process of document review and approval concerning validation.
  • Ensure compliance of QA controls with the company's best practices and standards.
  • Additional responsibilities will include assisting in other compliance activities to include: Recall Management, Annual product reviews, Regulatory Inspection logistics, and providing general compliance support for the overall Quality System in place at Wacker Biotech US.
  • Tracking and reporting compliance metrics.
  • Work with various user groups to facilitate auditing and training processes.
  • Providing general compliance support for the overall Quality System in place at Wacker Biotech US.
  • Performs other QA related duties and ad hoc projects as required by position and management.

Qualifications

  • BA/BS in a scientific discipline with a minimum of 5 years of experience in biotechnology or pharmaceutical industry or MS with a minimum of 3 years of experience
  • Minimum 5 years of experience in a regulated industry; Quality Assurance role required
  • Other requirements include: Excellent organizational skills; ability to work independently and in team environments; understanding of FDA/EU GMP/GCP/GLP Quality Requirements; familiarity with FDA current Good Manufacturing Practices and Good Documentation Practices.
  • Through knowledge of GAMP 5, GMP, GCP, GxP documentation including 21 CFR Part 11 compliance
  • Experience in dealing with both US and EU Quality requirements with an understanding of a broad spectrum of QA GMP requirements.
  • Detail oriented and strong communication skills.
  • Ability to work in a high pace environment.
  • Critical thinking and problem-solving skills.
  • Proficiency in Microsoft Word, including editing, formatting, utilizing templates, creating forms, and embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is a plus.
  • Experience in working within document control systems is preferred.
  • Experience with Electronic Document and Quality Management Systems preferred.
  • Position may require 25-35% travel.

 

Sustainability is one of WACKER’s corporate goals – also as an employer. We want you to remain productive, healthy and successful long term. That is why we offer, for example, comprehensive health management and a variety of advanced training programs and courses for individual development opportunities, alongside a good work-life balance. Naturally, we also have a fair compensation system and above-average social benefits. After all, social responsibility has a long tradition at WACKER.

 

Be part of a family. Across all nations.

 

We are looking forward to your online application at www.wacker.com/careers
Reference Code: 4551

 

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Nearest Major Market: San Diego