Quality Assurance Specialist
Talascend is currently seeking a Quality Assurance Specialist for a contract opportunity with our client in Hazelwood, Missouri, working a hybrid schedule.
Overview
The Quality Assurance Specialist supports externally manufactured products with a product portfolio that includes pharmaceutical and biopharmaceutical products. The position is responsible for assisting in the review and writing of quality systems documentation and working with internal and external counterparts.
Responsibilities
- Review of stability reports, data evaluation, and record management
- Review and approval of CMO documentation for batch production
- Review of batch records, addressing discrepancies and escalating where required to management
- Review, input, and routing of quality agreements
- Quality record management; deviations, change controls, CAPAs
- Monitoring cold-chain transportation, for both qualification and routine
- Annual Product Quality Review assessment and authoring (certain sections)
- Writing quality systems documents
- Working within MasterControl for authoring, reviewing, routing, and approving
- Regular telephone and email communication with internal partners to ensure timely manufacture and resolution of quality issues for product
- Support continuous improvement projects
Qualifications
- Bachelor's degree in scientific discipline, preferred 5+ years experience working within quality roles with increasing responsibility
- Direct experience working with quality systems (deviations, change controls, training, supplier qualification and document management systems)
- Knowledge of cGMP requirements for pharmaceutical manufacturing, specifically CFR 210/211
- Sterile injectable pharmaceutical experience preferred
Requirements
- Strong organizational skills
- Works independently
- Knowledge of Microsoft Office Suite
- MasterControl experience a plus
- Good interpersonal skills; ability to communicate well, both verbally and written
- Able to function effectively in teamwork environment
- Thorough, diligent and good attention to detail
- Collaborator with strong levels of engagement with individuals and team
- High level of delivery and work completion
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.