C&Q Subject Matter Expert

Stark Pharma Solutions Inc
North Carolina

Job Title: C&Q Subject Matter Expert (SME)
Location: Onsite, Holly Springs, NC
Duration: 6 20 months (Contract)
Experience: 5 - 7 Years

About the Role

Our client, a global biotechnology leader specializing in general medicine, rare diseases, inflammation, and oncology, is seeking experienced Commissioning and Qualification (C&Q) Subject Matter Experts . This role requires deep expertise in C&Q, with the ability to lead projects from initial workstream buildout through validation.

Key Responsibilities
  • Build, manage, and execute full C&Q workstreams.

  • Fully own 2 3 systems or equipment packages through to validation readiness.

  • Lead cross-functional teams, working closely with engineering, quality, and project leadership.

  • Develop, write, and execute FATs, protocols, and related documentation.

  • Provide clear, detailed updates and status reports to leadership.

Required Qualifications
  • Expert-level knowledge of the full C&Q lifecycle, from commissioning through validation.

  • Proven experience owning and delivering multiple packages from start to validation.

  • Hands-on downstream purification experience .

Preferred Qualifications
  • Strong communication and leadership skills.

  • Experience with solution preparation, equipment process, and chromatography.

  • Ability to confidently lead teams and present to stakeholders.

Posted 2025-08-19

Recommended Jobs

Packaging Operations Operator 1

Industrial
Mebane, NC

Roles & Responsibilities Perform manual inspection, labeling, and packaging of finished products. Ensure packaging meets Quality specifications and procedural standards. Inspect in-process c…

View Details
Posted 2025-08-19

Operations and Planning Analyst

IQUASAR LLC
North Carolina

Job Description Job Description Benefits: ~401(k) ~401(k) matching ~ Competitive salary ~ Dental insurance ~ Health insurance ~ Paid time off ~ Training & development ~ Vision insu…

View Details
Posted 2025-07-30

General Automotive Technician

AAMCO Transmissions and Total Car Care
Rocky Mount, NC

As a General Automotive Technician you will be called upon to service a broad range of vehicle repair issues and for quickly identifying the cause of performance problems.  Position Responsibilitie…

View Details
Posted 2025-07-30

Certified Nurse Assistant (CNA)

Interim HealthCare of Wallace, NC
Wallace, NC

Job Description Job Description Interim Healthcare of the Eastern Carolinas is seeking Certified Nursing Assistants (CNA) to provide home care services to clients in their homes throughout Duplin…

View Details
Posted 2025-07-25

Cardiothoracic Surgery Physician Assistant Job Near Wilson, NC

Atlantic MEDsearch
Wilson, NC

Job Description Job Description Well-established surgical group seeks a Board-Certified Physician Assistant or RNFA certified Nurse Practitioner to assume the role of Cardiac Surgery First Assist…

View Details
Posted 2025-07-27

Embrace the Charm of Franklin: Travel RN Opportunity!

NurseRecruiter
Franklin, NC

RN PCU job in Franklin, NC Embark on an enriching journey as a Travel RN in the charming city of Franklin! Experience vibrant local culture, historical landmarks, and lush parks while growing your ca…

View Details
Posted 2025-07-30

OB/GYN Physician - Partner Track! 350K!

NP Now
Greensboro, NC

Private Group seeking an Obstetrics and Gynecology Physician in Greensboro, North Carolina! Fantastic income and partnership potential available with this role! Contact: Raymond Stiles (843-574-…

View Details
Posted 2025-07-28

Regional Director

PRG Real Estate
Cary, NC

Job Description Job Description PRG Real Estate is seeking a dynamic and experienced Regional Director to lead our Raleigh, NC, portfolio of 1,600 multifamily units. This position reports to the …

View Details
Posted 2025-07-27

Staff Accountant

D R Allen & Son
Fayetteville, NC

Perform Accounting duties within a fast-paced finance department while adhering to established standards while serving as a resource for the accounts payable and accounts receivable teams. Provide …

View Details
Posted 2025-08-20

Customer Service Associate

Variety Stores LLC
Concord, NC

Job Description Job Description Big Lots is seeking motivated individuals to support our Stores as we provide essential products at great values to the communities we serve. Summary As a Bi…

View Details
Posted 2025-07-30