QC Scientist in Sanford, NC 27330

SourceAbled is seeking candidates for a Direct Hire role as a QC Scientist with our client, one of the world’s largest pharmaceutical companies.

Qualified candidates with disabilities, autism, or other forms of neurodivergence in Sanford, NC or willing to relocate are strongly encouraged to apply.

Join the Mission for Quality and Patient Safety

The Quality Control Analytical team is on the lookout for a dynamic and seasoned individual to bolster analytical non-testing activities within the Raw Materials group at our Andover site. In this role, you'll be at the forefront of crafting procedures, test methods, and technical documents. Collaboration is key, as you'll work closely with cross-functional teams including QC Raw Materials, QC Microbiology, Quality Assurance, Warehouse, Supply Chain, and Site Technical Services.

Your role extends beyond documentation. You'll actively engage in scheduling, metrics tracking, and the pursuit of continuous improvement. We value team players who embody excellence, integrity, inclusivity, and a drive for continuous enhancement. Recognize your contribution and be part of our journey toward excellence.

How You'll Thrive

• Craft and review essential technical documents like raw material specifications, standard operating procedures, test method investigations, and change controls.
• Represent Quality Control Analytical in cross-functional meetings.
• Support both internal and external audits.
• Strategically plan and prioritize tasks to ensure seamless operations.
• Handle analytical documentation of raw material samples with precision.
• Keep meticulous records in compliance with cGMP (current good manufacturing practices) and quality standards.
• Meet all deadlines and deliverables as part of our plan of record.
• Address atypical or out-of-specification test results and actively participate in investigations for resolution and correction.
• Scrutinize data and documents to ensure compliance and accuracy.
• Participate wholeheartedly in the culture of continuous improvement within the raw materials group, utilizing the latest tools.
• Embrace these Core Values: Courage, Excellence, Equity, and Joy

Qualifications

Must-Have:

• High School Diploma (or Equivalent) with 8 years of relevant experience OR an associate's degree with 6 years of experience OR a bachelor's degree with at least 3 years of experience OR a Master's degree with more than 1 year of experience.
• Experience in a GMP pharmaceutical QC testing laboratory environment.
• Proficiency in relevant analytical techniques (raw material testing, wet chemistry testing, analytical testing).
• Strong technical writing skills, including investigations.
• Demonstrated  abilities in decision-making, planning, and prioritization, with a focus on team success to meet defined metrics and timelines.
• Proficiency with computer systems (Microsoft Office applications, LIMS, etc.).
• Strong oral and written communication skills.
• Self-motivated with adaptability in rapidly changing project priorities.

Nice-to-Have:

• Experience in QC Raw Material testing and documentation.
• Knowledge and experience with cGMP, USP/EP/JP, regulatory guidance, and audits.
• Familiarity with electronic document management systems and laboratory information management systems such as LIMS, SAP, PDocs, and Trackwise (preferred).
• Experience in authoring and reviewing QC documentation, including SOPs and test methods.
• Proficiency in authoring quality documents such as change controls, CAPAs, and deviations.
• Experience with DMAIC, lean, and continuous improvement tools (desirable).