Onsite QC Lab Services Analyst - GMP & Equipment

Lancesoft; Wilson (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Lancesoft is seeking a QC Lab Services Analyst for our Wilson, NC facility. The role focuses on analytical equipment lifecycle management, CSV support, and qualification activities tied to HPLC, Endotoxin, and Cell Culture testing.

The ideal candidate has a pharma background with at least 2 years in quality control, familiarity with GMP, and experience with eLIMS and SOP/document drafting. This is an onsite, contract role through 04/28/2028 in Wilson.

Qualifications

• Bachelor's degree in chemistry, biochemistry, micro or related field with 2+ years related experience in biopharmaceutical or pharmaceutical industry.
• And/or an equivalent combination of education and experience.
• Working knowledge of regulatory requirements, policies, and guidelines.
• Experience with Quality Control document reviews and regulatory inspection processes.
• Working knowledge of laboratory systems.
• Strong technical knowledge in and experience with QC analytical equipment is required.
• Knowledge of cGMP regulations and FDA/EU guidance is required.

Responsibilities

• Participate in the qualification of analytical equipment for related testing functions, for example, IQ/OQ/PQ of HPLC, Spectrophotometry, Endotoxin, Cell Culture and Total Organic Carbon equipment.
• Author SOP s, Work Instructions, and protocols.
• Responsible for the quality control laboratory equipment lifecycle management and CSV support.
• Participate in activities to introduce technologies and computer base applications to a new site, for example eLIMS/iLABS, SDMS, Empower and SoftMax Pro, SAP, to improve laboratory efficiency and promote a culture of Innovation.
• Interact with the QC Global organization for the different center of excellence for equipment and information technologies.
• The resolution of unexpected complex compliance or lab instrument and system issues as they arise.

Skills

Quality Control experience

Regulatory compliance knowledge

Analytical thinking

Education

Bachelor's degree in chemistry/biochemistry/microbiology or related field

Tools

eLIMS

iLABS

SDMS

Empower

SoftMax Pro

SAP

Job description

Lancesoft is seeking a QC Lab Services Analyst for our Wilson, NC facility. The role focuses on analytical equipment lifecycle management, CSV support, and qualification activities tied to HPLC, Endotoxin, and Cell Culture testing.

The ideal candidate has a pharma background with at least 2 years in quality control, familiarity with GMP, and experience with eLIMS and SOP/document drafting. This is an onsite, contract role through 04/28/2028 in Wilson.