QA Specialist II (Pharma)

Pace® Analytical Services•Morrisville, NC

About The Position

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 fast‑paced, 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, detail‑oriented, and comfortable working both independently and cross‑functionally, with a strong interest in continuous learning and process improvement. Collaboration with our Raleigh, NC QA team will be routine.

Requirements

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.
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)

Nice To Haves

Experience hosting and supporting regulatory and customer audits

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