Quality Assurance Specialist

We are looking for a Quality Assurance Specialist to support laboratory quality operations in Reading, Pennsylvania. This Long-term Contract position will focus on strengthening quality systems, maintaining accurate documentation, coordinating sample activities, and helping ensure materials and products meet established standards. The role offers the opportunity to contribute to laboratory best practices, compliance readiness, and ongoing process improvement within a regulated environment.

Responsibilities:
• Create, review, and maintain quality documents such as standard operating procedures, work instructions, forms, logs, and Certificates of Analysis to support compliant laboratory operations.
• Manage the full sample lifecycle by collecting, preparing, labeling, tracking, and submitting materials for internal assessment and external laboratory testing.
• Oversee retention sample activities, including inventory control, storage organization, traceability, and disposal in line with approved procedures.
• Support the development and refinement of the quality control program by helping establish laboratory workflows, testing practices, and operational standards.
• Maintain document control and records management processes to ensure quality files are accurate, current, and readily accessible for review.
• Partner with third-party testing providers to coordinate submissions, monitor status, and keep detailed testing records.
• Assist with audit preparation and compliance efforts by organizing documentation and supporting quality system readiness activities.
• Perform and document physical, chemical, or analytical testing as needed, and communicate findings clearly to relevant stakeholders.
• Contribute to investigations involving nonconforming results or product quality issues, helping identify causes and support corrective actions.• Associate degree or bachelor’s degree in chemistry, biology, laboratory science, quality assurance, or a related discipline is preferred.
• At least 2 years of experience in laboratory operations, quality control, quality assurance, or a regulated manufacturing setting is preferred.
• Strong technical writing skills with the ability to produce clear procedures, reports, and controlled documentation.
• Working knowledge of quality systems, document control practices, and compliance expectations within regulated environments.
• Ability to organize sample records, laboratory documentation, and quality data with a high level of accuracy and attention to detail.
• Familiarity with audit support activities and quality investigations related to testing or product concerns.
• Understanding of laboratory equipment, testing processes, and standard quality control procedures.
• Experience in pharmaceutical, food-grade, chemical manufacturing, or similar regulated industries is preferred.