Talascend is currently seeking a Quality Assurance Specialist for a contract opportunity with our client in Hazelwood, Missouri.
Overview
The Quality Assurance Specialist supports externally manufactured products, including pharmaceutical and biopharmaceutical items, by managing quality processes and vendor relationships to ensure compliance with industry standards.
Responsibilities
- Prepare, review, and approve CMO documentation for batch production and review batch records for discrepancies, escalating issues as needed.
- Support oversight of third-party supplier activities related to manufacturing, packaging, and testing of products.
- Maintain communication with CMOs to ensure timely manufacture and resolution of quality issues.
- Monitor product performance from CMOs and manage quality records, deviations, change controls, and CAPAs.
- Oversee cold-chain transportation qualification and routine monitoring.
- Manage CMO maintenance and contribute to technical quality agreements.
- Provide post-launch support for quality activities across various countries.
- Manage delegated projects and review/approve stability program protocols and data.
- Drive audit readiness programs, perform supplier audits, and support continuous improvement initiatives.
Qualifications
- Bachelor's Degree in a scientific discipline.
- Minimum of 5 years of experience working in quality roles with increasing responsibility, preferably 7+ years.
- Experience with quality systems such as deviations, change controls, training, supplier qualification, and document management systems.
- Knowledge of cGMP requirements for pharmaceutical manufacturing, specifically CFR 210/211 and CFR 820; familiarity with GDP, ISO 17025, and 13485.
- Experience with sterile injectable pharmaceutical products.
- Demonstrated ability to perform the duties of this position through relevant experience, training, or education.
We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.
Background Check and Drug Screen may be required.
Talascend is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.