Quality Assurance Specialist II

Curia • Springfield, MO

2d • Onsite

About The Position

The Quality Assurance Specialist II serves as a quality partner to manufacturing and laboratory operations, providing on-the-floor oversight, data and documentation review, and proactive compliance support. This role identifies and addresses compliance risks, supports resolution of quality events, and helps ensure manufacturing and laboratory activities are performed in accordance with cGMPs, data integrity principles, and Curia procedures. The QA Specialist II supports Curia’s Quality Management System through analytical data review, quality event management, audit support, and maintenance of quality systems and records while collaborating across functions to promote consistent, compliant execution.

Requirements

• Bachelor’s degree in Life Science, Chemistry, Biology, or a related scientific discipline; relevant education and experience may be considered in lieu of a degree.
• 3–6 years of Quality Assurance, Quality Control, laboratory, manufacturing, or related experience within a pharmaceutical, biotechnology, medical device, or other FDA-regulated cGMP environment.
• Experience reviewing cGMP documentation and/or analytical laboratory data for completeness, accuracy, compliance, and adherence to approved procedures and specifications.
• Working knowledge of FDA regulations, cGMP requirements, Good Documentation Practices, and data integrity principles, including ALCOA+.
• Ability to identify and evaluate documentation, data integrity, quality, and compliance concerns and appropriately escalate issues when needed.
• Strong critical-thinking, problem-solving, organizational, and attention-to-detail skills with the ability to manage multiple priorities in a fast-paced cGMP environment.
• Effective written and verbal communication skills with the ability to work independently and collaboratively across functions.
• Proficiency with Microsoft Office and the ability to learn applicable electronic Quality, laboratory, documentation, and data management systems.
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Experience reviewing analytical laboratory and chromatographic data, including HPLC, GC, or other analytical instrumentation and associated data systems.
• Familiarity with 21 CFR Parts 210 and 211 and applicable ICH guidance, including ICH Q7, Q9, and Q10.
• Experience supporting deviations, investigations, CAPAs, change controls, audits, or regulatory inspections.
• Experience working in a pharmaceutical API manufacturing environment.

Responsibilities

• Provide on-the-floor QA oversight to manufacturing operations, proactively identifying compliance risks and supporting day-to-day quality activities.
• Represent Quality Assurance when issues require immediate corrective action, ensuring actions are appropriate, compliant, and accurately documented.
• Support the initiation, documentation, investigation, and resolution of deviations and other quality events.
• Monitor operations for compliance with approved procedures, batch records, protocols, cGMP requirements, and Good Documentation Practices.
• Partner with Manufacturing, Quality Control, Technical Services, and other functions to resolve quality issues, support real-time compliance, and escalate significant concerns to Quality Management.
• Provide guidance to personnel regarding cGMP requirements, site procedures, documentation practices, and quality expectations.
• Review Quality Control analytical testing and associated data for completeness, accuracy, traceability, and compliance with approved methods, specifications, SOPs, cGMP requirements, and data integrity principles.
• Review analytical documentation, including chromatography and other laboratory-generated data, as applicable, to verify appropriate execution, calculations, results, and adherence to established procedures and specifications.
• Identify discrepancies, atypical results, documentation errors, and potential data integrity concerns and partner with laboratory personnel and Quality Management to ensure appropriate evaluation and resolution.
• Review manufacturing and quality documentation, including batch records, protocols, controlled forms, and other cGMP records, for completeness and compliance.
• Apply sound judgment and critical thinking when reviewing data and documentation and ensure corrections or clarifications are completed in accordance with Good Documentation Practices.
• Author, review, and/or approve Quality Management System documentation, including SOPs, deviations, change controls, CAPAs, controlled forms, and other quality records within assigned authority.
• Support investigations through documentation and data review, information gathering, and evaluation of immediate actions.
• Maintain Quality databases, electronic systems, training records, controlled documents, archives, and other cGMP records as assigned.
• Assist with Quality System metrics and other information used for management review.
• Participate in internal audits, client audits, regulatory inspections, and other quality assessments, including gathering and reviewing supporting documentation and completing assigned follow-up actions.
• With appropriate guidance, support responses to clients regarding manufacturing, testing, documentation, and quality-related issues.
• Support QA visual inspection activities as required.
• Maintain required training and provide guidance or training to personnel on cGMP requirements, Good Documentation Practices, site procedures, and other quality requirements within areas of expertise.
• Identify opportunities to strengthen compliance, data integrity, documentation practices, and Quality System effectiveness.
• Collaborate across departments to promote a culture of quality, accountability, continuous improvement, and proactive problem solving.
• Perform all documentation in compliance with ALCOA++ principles and site SOPs.
• Adhere to applicable cGMP documents including SOPs, batch records, protocols, change controls, and controlled forms.
• Keep all required cGMP training current and escalate quality concerns along with proposed solutions to the Quality department.
• Apply data integrity principles when reviewing electronic and paper records, including source data, metadata, audit trails, and associated documentation, as applicable.

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level