QA Specialist Investigations - Pharmaceutical Manufacturing
WGA Consulting, LLC - Irvine, CA

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Company Background
WGA Consulting is a national boutique business management-consulting firm. We are passionate and dedicated to helping our clients make and execute the big decisions: on strategy, operations, transformation, technology, supply chain, quality, culture change, compliance, and organizational development. WGA's core belief, that as trusted advisors, we measure our results from the enduring financial success of our clients. This belief and passion can be seen in our growth, people, services, and relationships.
As a boutique management-consulting firm:
1. We place our clients' interests first, for we recognize that only through their success can we achieve ours.
2. We are a team of proven innovators, purpose-built to deliver world-class results to our clients around the world.
3. Our global client experience has allowed us to transform organizations across a broad spectrum of market segments and industries.
4. Our client successes have won us client trust and significant organizational knowledge while materially improving our clients’ financial and operational performance.
Position Summary:
A QA Specialist Investigations requires working in a high performing team environment that is responsible for supporting a client’s manufacturing operations including processing, packaging, warehouse, facilities, and the laboratory. The primary responsibility is to investigate and evaluate the impact of excursions on product quality. The candidate will be involved in trending critical parameters and conducting investigations for products in accordance with cGMPs and standard operation procedures. The candidate will interface directly with the client’s suppliers of raw materials, component vendors, and customers such as Supply Chain, Technical Services, Quality Control, and Manufacturing. The candidate will interact with the client’s internal and external compliance groups and regulatory agencies such as FDA, EU and other agencies. The position supports the client’s daily manufacturing operations and core hours are primarily day shift; coverage of off-shift and weekends will be periodically required to support the other members of the client’s team.
Candidate Qualification Requirements:

  • Minimum Verified Education (Accredited University):

o Undergrad cumulative GPA of 3.3 or higher in Chemistry or equivalent academic field of study
o Lean/Six Sigma Black belt or Kaizen Sensei certification from a recognized and accredited organization

  • Minimum Pharmaceutical QA Experience: 5 Years
  • Demonstrated proficiency in the following business tools:

o LIMS, SAP – Advance skill level
o Microsoft Project 2010 – Advance skill level
o Microsoft Powerpoint 2010 - Advance skill level (Infographics, create visual depictions of complex data and ideas)
o Microsoft Excel 2010 – Advanced skill level (Pivot Tables, Find valuable metrics in large volumes of data, Building templates and tools to analyze surveys )
o Microsoft Word 2010 – Advanced skill level
o Microsoft Outlook 2010 – Advanced skill level
o Microsoft Sharepoint 2010 – Advanced skill level
Job Responsibilities:

  • Understanding of cGMPs, process validation, and FDA Compliance requirements is a must. Must have excellent technical writing skills, including writing investigations
  • Problem Solving: Proactively seek solutions; gather and analyze information systematically; develop alternative solutions; think analytically and act decisively using research data as the basis for recommendations.
  • Master Complexity: competently handle day-to-day work challenges; thrive in uncertain circumstances; detail oriented and ability to work collaboratively across functional groups and handle multiple responsibilities and projects.
  • Communication: excellent oral and written communication skills. Write clearly and informatively; create documents that are complete and accurate.
  • Commitment: Attain quality results on time; convey a sense of urgency and drive issues to closure.
  • Deliver high value and quality results in short time windows
  • Passion and commitment to do what it takes to complete tasks on time, work independently and the discipline to complete tasks flawlessly
  • Able to digest complex and practical manufacturing practices and recommend innovative and industry practices to design a sustainable, easy to execute and deliver client solution
  • A strong professional compass and comfort when working with client executives
  • Comfortable taking prescriptive direction from WGA leadership team members and internal peers
  • Ability to adapt to ever-changing client projects and WGA leadership goals
  • Provide design recommendations regarding manufacturing processes and shop floor practices that are common in the pharmaceutical industry and are cutting edge or innovative.
  • Support the execution of action plans on client projects
  • Identify resistance and performance gaps, and work to develop and implement corrective actions
  • Evaluate, track, and report the progress of client services
  • Create and develop client delivery tools, templates, job-aids, procedures, engineering design

*Travel: 20% North America
Location: Multiple US Cities
Duration: 1 Year
Anticipated Rate: DOE *