QC Investigator

The Experienced Analyst Quality Control position for investigators supports the overall QC organization and is responsible for authoring nonconformance investigations and corrective and preventative action records, document management, investigation and assay trending, root cause problem solving and human performance factors analysis. This position requires analytical thinking, organizational leadership and technical writing skills. This position will drive improvements within a global organizational framework.
Responsibilities
Performs and documents all QC investigations (non-conformance, deviations, invalid assays)
Authors and execute corrective and preventative action records
Tracks deviations and events and provides reports to management on trending, and status as requested. Recommends corrective actions for any trends identified
Manages change through change control process
May perform Gap Assessments for local QC documents against new standards and other quality documents
Executes CAPAs when required for the Quality Control organization
Works with compliance to provide QC input for APR
Reports data from QC as required for the site management review
Maintains individual training completion in a compliant state
May be asked to participate in audits
Support Health Authority inspections
Provide input to functional laboratory meetings
Make decisions as a QC representative at cross-functional meetings
Provide leadership and insight as a member of global project teams
Provide QC input as a member of Quality focused projects

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here.

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Minimum of a bachelors degree is required
Minimum of 3 years of experience conductting invetsigations within a QC lab or relevant space
Strong experience within tehcnical writing of complex investigations
Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols is required
Proficiency in using Microsoft office applications (outlook, excel, word, and PowerPoint) is required

Experience with Flow Cyromtery and ELISA
Experience presenting investigation findings to auditors or regulatory agencies, including preparation of supporting documentation and responses to follow-up questions.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.