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Job Description

The QC Lab Services Analyst, External Sample Management-Raw Material Release Specialist, position supports the overall QC organization and is responsible for external lab sample management, raw material management, retains management, and document management in the QC organization and communication with global workgroups within the raw material area. This position requires organizational leadership, and interpersonal skills. This position will work cross-functionally and will drive improvements within a global organizational framework.

Responsibilities:

-Sample management for external testing.

-Retains inspections and discards.

-Handle external shipments.

-Process final reports from contract labs.

-Create and manage purchase orders.

-Handle test requests from outside customers (i.e R&D, external sites).

-Acquire and handle project quotes for external testing.

-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 the APR.

-Maintains individual training completion in a compliant state.

-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.

-May be asked to participate in audits.

-Support Health Authority inspections.

-Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

-Author, review and approve documents.

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 [email protected] . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

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Skills and Requirements

Requirements:

-A minimum of a bachelor's degree in science or equivalent technical field is required.

-A minimum of two years of experience within GMP pharmaceutical industry and quality setting

-Experience with SAP

-Skilled in basic understanding of LIMS systems.

-Knowledge and awareness of compendial requirements and standards for QC testing.

-Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols.

-Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).

- Ability to independently perform project management functions. -Experience working with raw materials or in a chemistry lab null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].