QA Specialist II (Pharma)

Shift:

Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward; to innovate and advance all aspects of our business to improve the health and safety of our communities and lives.

QA Specialist II (Pharma/Biotech)

Summary
Our State-of-the-art Analytical Testing Site, located in Morrisville, NC is seeking a QA Specialist II to support our Quality Assurance team in a fastpaced, collaborative environment focused on ensuring the safety and effectiveness of materials used in pharmaceutical, biologics, and medical device products. This role independently audits analytical projects, ensures compliance with applicable regulations (GLP/GMP), and provides quality oversight across multiple functions.

The ideal candidate is proactive, detailoriented, and comfortable working both independently and crossfunctionally, with a strong interest in continuous learning and process improvement. Collaboration with our Raleigh, NC QA team will be routine.

Key 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 decisionmaking.
• Partner on crossfunctional 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, highquality work environment

Qualifications

Education & Experience

• 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

Knowledge & Skills

• Strong understanding of quality systems, GLP/GMP regulations, auditing practices, and laboratory operations.
• Experience leading or participating in client audits strongly preferred
• 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, timemanagement, and independent judgment.
• Experience presenting information to various audiences.
• Proficient with computer systems and electronic data tools (i.e. Master Control and LiMS systems)

Find Your Place at Pace - We need you - your curiosity, your talents, and your drive - to help us advance this important work.

Benefits
When you join Pace, you commit to work that makes a positive impact on our communities and our world. We commit to supporting you with benefits and perks that make a positive impact on your life. Full-time roles are eligible for our comprehensive benefits program which includes 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 and ID theft.

Equal Opportunity Employer

Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.