Pace® Labs · 5 hours ago
QA Specialist II (Pharma)
Morrisville, NC
Full-time
Onsite
Mid Level
3+ years expPace® Labs is a state-of-the-art Analytical Testing Site located in Morrisville, NC, seeking a QA Specialist II to support their Quality Assurance team. The role involves auditing analytical projects, ensuring compliance with regulations, and providing quality oversight across multiple functions.
Executive Office
Responsibilities
Review and audit analytical data packages, technical records, SOPs, logbooks, quality exceptions, and LIMS entries (paper and electronic)
Conduct internal audits, lab walkthroughs, project archiving, and QA oversight of electronic data processes
Approve methods, protocols, and reports
Provide Regulatory assistance to internal teams and client regulatory support
Provide guidance to internal teams regarding quality policies, procedures, and compliance expectations
Analyze quality data to identify trends, recommend improvements, and support decision‑making
Partner on cross‑functional projects, including timelines, documentation, and deliverables
Support and Host routine Client Audits
Ensure adherence to cGMP, GLP, and applicable regulations
Support continuous improvement and promote a collaborative, high‑quality work environment
Qualification
Required
Bachelor's degree in Chemistry or related field
3–5 years of relevant QA experience in pharmaceutical, biotech, or regulated laboratory environments, or equivalent combination of education and experience
Experience hosting and supporting regulatory and customer audits
Strong understanding of quality systems, GLP/GMP regulations, auditing practices, and laboratory operations
Ability to identify compliance issues and propose solutions
Skilled in reviewing complex data, documentation, and reports with high attention to detail
Effective communicator with the ability to collaborate across teams and functions
Strong organizational skills, time‑management, and independent judgment
Experience presenting information to various audiences
Proficient with computer systems and electronic data tools (i.e. Master Control and LiMS systems)
Preferred
Experience leading or participating in client audits strongly preferred
Benefits
Competitive salaries
Medical
Dental vision
401K retirement savings plan (100% vested immediately in the employer match)
Life
Disability and voluntary benefits
Paid time off for holiday, sick and vacation days
HSA
Wellness program
Flexible spending accounts
Tuition reimbursement
Employee Assistance program
Parental leave
Optional legal coverage
ID theft
Company
Pace® Labs
Pace® works with organizations of all types, providing the science to ensure our air, water, therapies, and more are safe for use.
1001-5000 employees
H1B Sponsorship
Pace® Labs has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Late StageCompany data provided by crunchbase