Our client, a leading utility company, is hiring a Field Specialist QA Operations n a contract basis.
Specialist, QA Operations, is responsible for quality oversight on Gene Delivery Clinical Manufacturing Facility (S6A) in Summit, NJ and will ensure activities performed are in accordance with client policies, standards, procedures, and Global cGMP requirements. This position reports to the Senior Manager of Quality Assurance Operations.
Functional responsibilities include onsite coverage of and/or participation in:
• QA Shop Floor and QC Laboratory Walkthrough activities
• Label Printing and Issuance of finished drug product and shipping labels
• Event Triage including Deviation and CAPA QA Review and Approval
• Provides QA oversight on deviations, CAPAs and change controls
• Ensuring accurate and timely review, as well as maintaining, clinical manufacturing GMP/batch related documentation and procedures.
• Product disposition and raw material release
• Must have knowledge and Quality experience with cGMP manufacturing US and global requirements.
• Must possess an independent mindset and 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.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little supervision.
• Work is self-directed yet collaborative with CTD counterparts.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
• Follows established procedures and performs work as assigned and develops procedures as needed.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution. Proposes solutions for complex issues and works with management to resolve.
• Able to prepare written communications and communicate problems to cross-functional counterparts and management with clarity and accuracy.
DUTIES AND RESPONSIBILITIES:
• Provide functional QA oversight of S6A Manufacturing Operations, Warehouse, QA and QC Laboratory processes in the execution of clinical manufacturing of gene delivery materials.
• Participate in Shop Floor and Quality Check Walkthrough programs.
• Issuance of batch records
• Apply knowledge of quality processes, including batch record review, material disposition, triaging and review and approval of deviations, investigations, CAPA, risk management, change control, and product complaints.
• Revise department SOPs, as well as review and QA approval of CTD SOPs
• Perform review /approval of executed batch records.
• Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
• Supports Risk Assessments/projects as required by senior management.
EDUCATION AND EXPERIENCE (As Applicable):
• B.S. scientific discipline or relevant college / university degree required.
• Minimum 2 years cGMP work experience. Quality experience, preferred.
• Equivalent combination of education and experience acceptable.
• Strong knowledge of cGMP Quality and Compliance principles required.
• Clinical and Phase appropriate experience preferred.
• Strong cross-functional collaboration experience required.
WORKING CONDITIONS: (US Only):
• Review Work is performed in a typical office environment, with standard office equipment available and used. QA Shop Floor Coverage/Lab Walkthrough Work requires standing and walking for up to 90% of the time on a given day. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
• This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.