Quality Assurance Specialist II *PC

Your Role

This position supports daily Quality Assurance activities at the Auburn site, including material release, documentation and archival management. The role ensures compliance with GMP, GDP, and company procedures while contributing to site inspection readiness and long-term QA system development.

• Provide on-site QA support by monitoring daily operations for compliance and promptly reporting any quality concerns or high-risk issues to management.
• Assist with maintaining QA systems such as Deviation, CAPA, Change Control, Supplier Qualification, and Document Control. Support SOP revisions, ensure procedures are followed, and participate in staff training as directed.
• Prepare and review documentation for accuracy, completeness, and compliance with GMP, GDP, and ISO standards. Escalate issues or inconsistencies to QA management for further evaluation.
• Support internal and external audits by organizing evidence, coordinating assigned responses, and tracking timely completion of follow-up actions within QA systems to maintain inspection readiness.
• Perform on-floor GDP checks and self-inspections to verify compliance and identify improvement opportunities.
• Execute day-to-day tasks of the Material Release Program, ensuring all required documentation is complete, accurate, and compliant with GMP, GDP, and company procedures. Escalate any discrepancies or release holds to QA leadership for final review and disposition.
• Execute day-to-day tasks of the Quality Documentation and Archival Program, including document issuance, reconciliation, scanning, and retrieval to ensure inspection readiness.
• Collaborate with cross-functional teams and other sites to support harmonization efforts, validation activities, and continuous improvement initiatives.
• Support a developing site environment by performing core QA tasks and adapting to evolving systems and workflows. Demonstrate flexibility, attention to detail, and a willingness to learn as processes mature.
• Continue developing proficiency toward independent system ownership and advanced QA review.

• Bachelor's Degree in biological or life sciences, engineering; 2-4 years of experience in Quality Assurance, GMP manufacturing, or GMP distribution.
• Working knowledge of GMP/GDP principles and basic understanding of ISO 9001 or ISO 13485 systems.
• Experience supporting QA activities such as documentation review, deviations, or product release.
• Exposure to internal or customer audits and willingness to learn audit preparation and response coordination.
• Familiarity with ENNOV, SAP, or similar eQMS tools preferred.

• Good written and oral communication skills.
• Excel and SAP ERP Systems.
• Ability to prioritize and manage multiple tasks.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel;

reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers.

While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment. The noise level in the work environment is usually moderate.

The hiring range for this position is expected to fall between $79,300 - $107,300/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible…