Quality Assurance Documentation Supervisor
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Apply Now Application ends in 22d 18h 57min
Job Detail
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Offered Salary 0
Job Description
Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish an inclusive line between that purpose and our day-to-day work.
We are looking for motivated candidates to apply to our exciting Quality Assurance Documentation Supervisor role, in our brand-new Frederick MD facility.
- Shift – Wednesday- Saturday, day shift (4x 10 hour days)**
Responsibilities
- Supervise on the floor Document Control and Label Control operations and oversee direct reports
- Develop Document Control Team, provide the necessary training, ongoing coaching, discipline, recognition of direct staff, perform employee evaluation, and conduct regular one on one meetings.
- Handle and mitigate on the floor issues as they occur ensuring adherence to Business, HR and Operational policies.
- Ensure collaborative and positive working relationship with staff, supervisors and project lead
- Maintain a document management system aligned with regulatory, quality, and Kite requirements.
- Responsible for the administration of all documentation and records issuance and archival processes to support manufacturing process.
- Provide consultancy and advice on approved procedures, standardization and requirements associated with the document management system.
- Responsible for improving, executing and maintaining the document change control system.
- Excellent understanding of quality systems and regulatory requirements.
- Ensure accuracy by reviewing documents for completeness, proper authorization and impact to other quality systems.
- Collaborate with cross-functional departments to ensure timely implementation of document change controls and requests.
- Issue effective documents including procedures, test methods, specifications, and batch documentation.
- Assign lot related documentation and labels for manufacturing process.
- Issue GMP documentation for implementation including qualification and test methods.
- Support tracking and communication of site metrics to ownership
- Identify and raise compliance gaps across the document management system.
- Implement critical initiatives to improve the document management system.
- Investigate deviations against the document management system and develop effective corrective action plans.
- Provide training to new staff on document management processes, procedures and label issuance.
- Support audits (internal, external) as document management SME.
Basic Qualifications:
- Master’s Degree and at least 3 years’ experience in working within quality document management, quality engineering, quality assurance or quality systems OR
- Bachelor’s Degree and at least 5 years’ experience in working within quality document management, quality engineering, quality assurance or quality systems OR
- High School Degree and at least 9+ years’ experience in working within quality document management, quality engineering, quality assurance or quality systems.
Preferred Qualifications:
- Quality systems demonstrated thorough understanding in areas such as document management, document change control audits, batch record and label issuance.
- Excellent knowledge of GMP, SOPs and quality system processes.
- Excellent organizational skills
- Proficient in MS Word, Excel, Power Point ,Adobe Pro, and electronic document management systems(Document Locator, Documentum, Veeva or equivalent).
- Works on multiple assignments in collaboration with various department system owners.
- Ability to communicate and work independently with scientific/technical personnel.
- Excellent interpersonal, verbal and written (including editing) communication skills are crucial in this collaborative work environment.
- Comfortable in a exciting environment with minimal direction and able to adjust workload based upon changing priorities.
- Adaptable and comfortable in a collaborative and inclusive company environment
Apply Now
Application ends in 22d 18h 57min