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QA Specialist
Careers Integrated Resources Inc
Warren, NJ (Onsite)
Contractor
Job Title: QA Specialist
Job Location: Warren, NJ (100% Onsite!)
Job Duration: 6-7 Months (possibility of extension)
Job Summary:
Job Location: Warren, NJ (100% Onsite!)
Job Duration: 6-7 Months (possibility of extension)
Job 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.
- 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
- 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.
- B.S. degree required, minimum of 2 years of experience in the pharmaceutical or related industry.
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