Quality Assurance Analytical Specialist

Piper Companies is seeking a Quality Assurance Analytical Specialist for an onsite long-term contract position in Durham, North Carolina (NC). The Quality Assurance Analytical Specialist will be responsible for supporting quality assurance and compliance efforts in a regulated life sciences environment. This role involves performing analytical testing, data validation, and documentation review to ensure compliance with GMP, FDA, and ISO standards.

Responsibilities of the Quality Assurance Analytical Specialist:

• Oversee the review and approval of laboratory data.
• Ensure compliance with GMP requirements, Good Documentation Practices, and possess a strong analytical background.
• Proficient in handling CAPAs, Change controls, Deviations, Out of Specifications, and Laboratory investigation records.
• Experience with LIMS is advantageous, though most tasks will involve paper records.

Qualifications for the Quality Assurance Analytical Specialist:

·      3-6 years in a cGMP regulated environment within biopharmaceuticals or equivalent.

·      Experience in QA review and approval of quality systems records such as LIRs, Deviations, CAPA, and Change Controls.

·      Knowledge of USP, EU, JP, and cGMP guidelines.

·      Strong organizational skills and attention to detail required to ensure accuracy and efficiency in all tasks.

·      Ability to interpret business and technical documents, write reports and manuals, and effectively present information to various audiences.

·      B.S. in chemistry, biology, or a related scientific field.

Compensation:

• Salary Range: $40-$50 an hour, depending on experience level.
• Comprehensive Benefits: Sick leave if required by law, medical, dental, vision, 401K

This job opens for applications on 3/5/2025. Applications for this job will be accepted for at least 30 days from the posting date.