Quality Assurance Specialist

Quality Assurance Specialist

The Quality Assurance Specialist supports externally manufactured pharmaceutical and biopharmaceutical products, with a particular focus on sterile injectable lines. This role oversees contract manufacturing organizations (CMOs), ensures compliant batch release, and maintains robust quality systems and relationships with external partners. The specialist escalates critical issues to senior leadership when necessary and contributes to continuous improvement across the product portfolio.

Responsibilities include preparing, reviewing, and approving CMO documentation related to batch production to ensure accuracy, completeness, and compliance with applicable regulations and internal standards. The role also involves reviewing batch records thoroughly, identifying and addressing discrepancies, and escalating issues to senior management when required to support timely and compliant product disposition. Additionally, the specialist prepares disposition documentation and release certifications for reviewed batch records to enable compliant product release to the market.

Support oversight of third-party supplier activities involved in the manufacture, packaging, and testing of pharmaceutical and biopharmaceutical products, ensuring adherence to quality expectations. Maintain regular telephone and email communication with CMOs to coordinate timely manufacture, address quality concerns, and resolve issues impacting product supply. Continuously monitor product quality and CMO performance, using data and metrics to identify trends, risks, and opportunities for improvement.

Manage quality records, including deviations, change controls, corrective and preventive actions (CAPAs), and training records, in alignment with established quality systems. Monitor cold-chain transportation for both qualification and routine operations, ensuring temperature-controlled logistics meet quality and regulatory requirements. Contribute to the maintenance and improvement of CMO oversight processes, including documentation, performance monitoring, and quality governance.

Provide input into Technical Quality Agreements with CMOs to clearly define quality responsibilities, expectations, and communication pathways. Support post-launch quality activities for products, including ongoing monitoring, issue resolution, and lifecycle management of quality documentation. Manage delegated quality projects, ensuring clear planning, execution, and communication of progress and outcomes to stakeholders.

Review stability study protocols and associated documentation, ensuring they meet regulatory and internal quality requirements. Oversee stability program documentation review and management, ensuring data integrity and appropriate evaluation of product stability results. Contribute to the audit readiness program to maintain continuous audit compliance, ensuring systems, records, and processes are prepared for inspections at all times.

Perform supplier audits as required, evaluating quality systems, compliance with cGMP, and overall suitability of suppliers; a CQA certification is preferred for this activity. Lead or support quality and QMS-related projects as needed, aligning project outcomes with strategic quality objectives. Champion continuous improvement initiatives at CMOs, identifying and implementing enhancements to processes, documentation, and systems to strengthen product quality and reliability.

Collaborate cross-functionally with internal stakeholders to ensure alignment on quality standards, regulatory expectations, and operational priorities. Escalate significant quality or compliance issues to Manager/Director-level leadership and above, providing clear analysis and recommendations for resolution.

Essential Skills include a Bachelors degree in a scientific discipline, approximately 5+ years of experience in Quality roles with increasing responsibility, with 7+ years preferred. Direct experience working with Quality Systems, including deviations, change controls, CAPAs, training, supplier qualification, and document management systems. Strong knowledge of cGMP requirements for pharmaceutical manufacturing, specifically CFR 210/211 and CFR 820. Knowledge of Good Documentation Practices (GDP). Hands-on experience with batch record review and batch disposition processes. Experience in document control and quality system administration within a pharmaceutical environment. Sterile injectable pharmaceutical experience, including support of sterile manufacturing lines. Experience with supplier qualification and oversight, including interaction with CMOs and third-party manufacturers. Ability to manage and interpret quality data related to deviations, CAPAs, and change controls to drive effective decisions. Proficiency in managing quality records and documentation within electronic or paper-based document management systems. Understanding of FDA expectations related to quality assurance, cGMP, and pharmaceutical manufacturing. Experience supporting or conducting audits of suppliers or manufacturing sites. Strong written and verbal communication skills to interact effectively with CMOs and internal stakeholders. Ability to work independently in a remote environment while managing multiple quality responsibilities and projects.

Additional Skills & Qualifications include Certified Quality Auditor (CQA) certification is preferred for performing supplier audits. Experience in quality assurance within the pharmaceutical or biopharmaceutical industry, particularly with sterile injectables, is highly desirable. Familiarity with Quality Management Systems (QMS) and continuous improvement methodologies. Experience with training programs and ensuring compliance with documented procedures. Background in monitoring cold-chain transportation and understanding temperature-controlled logistics requirements. Ability to contribute to and interpret Technical Quality Agreements with CMOs and other partners. Experience participating in or leading audit readiness initiatives to maintain inspection readiness. Strong organizational skills and attention to detail for managing complex quality documentation and records. Ability to build and maintain productive relationships with external manufacturing partners and cross-functional internal teams.

Work Environment is a 100% remote work environment, supporting quality activities for sterile injectable pharmaceutical products manufactured at a large multi-site operation. The role follows Monday through Friday business hours, with flexibility to start between 7:00 and 9:00 a.m., and consists of standard 8-hour workdays. No overtime is required.

Job Type & Location is a Contract position based out of Hazelwood, MO.

Pay and Benefits range from $38.00 - $43.27/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type is fully remote.

Application Deadline is anticipated to close on Oct 15, 2026.