Collaborates with Supply Chain and Planning to ensure timely delivery of product. Reviews/approves executed batch records to ensure consistency with established standards. Continuous assessment of processes and procedures to identify continuous improvement opportunities. Collates quality related data and monitors product release metrics.
Essential Duties & Responsibilities:
Collaborates with Supply Chain/Planning and Manufacturing to coordinate release and shipment of product.
Performs release of finished bulk product for packaging. Performs necessary SAP transactions for material movement and dispositions.
Reviews/audits all data obtained during quality assurance activities to ensure consistency with company policies and procedures.
Reviews and approves lab test results for finished bulk product.
Participates in site Operational Excellence projects that drive enhancement to processes.
Collates quality related data and monitors product release metrics.
Writes, reviews company GMP-related SOPs.
Trains new employees on quality assurance procedures.
Maintains a working knowledge of government and industry quality assurance codes and standards.
Writes investigations and implements corrective actions.
Performs reviews of batch records as needed.
Other duties as assigned.
BA/BS or equivalent experience required. (degree in science preferred)
3-5 years pharmaceutical industry experience in a Quality Assurance environment (oral solid dose preferred).
Working knowledge of SAP required
Knowledge/experience in DEA procedures for controlled substances desirable.
Working knowledge of computers (Word, Excel, Access, etc.) required.
Excellent verbal, written, and interpersonal communications skills.
Interacts with people effectively. Able and willing to share and receive information.