QA Specialist

100% Onsite!

Position Summary

The Specialist is responsible for quality and disposition activities in accordance with company policies, standards, procedures and Global cGMP. Functional responsibilities include performing incoming material release and product release, ensuring accurate and timely maintenance performing document issuance for manufacturing.

Duties/Responsibilities

• Reconciliation, and archival of Batch records.
• Issue production batch documents Operations teams.
• Responsible for scanning documents and uploading into QMS system.
• Responsible for disposition of incoming production materials.
• Responsible for release activities for site manufactured drug product.
• Issue production batch records and product labels to Operations.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Able to effectively multi-task.
• Reporting Relationship Reports to Senior Manager, Quality Assurance Disposition

Qualifications Required Competencies: Knowledge, Skills, and Abilities

• Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, coaching others, and analytical thinking.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.
• Proposes solutions for complex issues and works with management to resolve.
• Follows established procedures and performs work as assigned.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Is recognized Subject Matter Expert within the group.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.

Education/ Experience/ License/ Certification

• B.S. degree required, minimum of 2 years of experience in the
• pharmaceutical or related industry.