Quality Assurance Specialist
Talascend is currently seeking an Quality Assurance Specialist for a contract opportunity with our client in Birmingham, Alabama.
Overview:
The role involves providing support for room clearance prior to and during manufacturing, reviewing production campaign documentation, and performing batch record review and final disposition of finished products.
Responsibilities:
- Provide support room clearance prior to and during manufacturing
- Review production campaigns documentation for products
- Perform batch record review and final disposition of finished product
- Review data and perform raw material and fill/finish component disposition
- Review clean room logbooks
- Review data to support the testing of site utilities (e.g. WFI, steam, nitrogen, etc.)
- Update, review and/or approval of QMS documentation in document control system (Regulus) e.g. SOP, work instructions, forms, specifications
- Provide on-the-floor support during manufacturing campaigns for products and services
- Provide on-call support during manufacturing operation
- Issuing product labels
- Perform label reconciliation
- SAP support reviewing inspection plans
- GMP monthly monitoring of the facility (labs, manufacturing, warehouse)
- Additional tasks may be assigned based on experience and business need
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.