QA Team Lead

Kite Pharma•Frederick, MD

4d•Onsite

About The Position

We are seeking a highly motivated individual to join us as a Quality Assurance Team Lead. In this role you will support the activities of the Quality Assurance department at Kite’s Frederick, MD manufacturing site. The Quality Assurance Team Lead will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality objectives. Shift is Sun-Wed 5:00 pm- 3:30 am

Requirements

MA/MS in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 3+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product)
BA/BS in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product)
Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 7+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product)
High School diploma and 9+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).

Nice To Haves

Thorough knowledge of GMP, SOPs and Quality Systems
Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards
Ability to effectively negotiate and build collaboration amongst individuals
Strong teamwork and collaborative skills
Experience with manufacturing investigations, deviations, and CAPA.
General knowledge of aseptic manufacturing processes.
Proficient in MS Word, Excel, Power Point and other applications.
Strong interpersonal, verbal and written communication skills
Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
Willingness to think outside of the box and adapt best practices to a small, but growing environment
Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficiencies
Self-motivated,detail-oriented,andwillingtoaccepttemporaryresponsibilitiesoutsideofinitialjob description.
Create Inclusion by demonstrating the business value of diverse and inclusive teams and embedding equity and respect into day to day people management practices.
Develop Talent by understanding team members skills experience aspirations and potential and providing coaching feedback and development opportunities.
Empower Teams by connecting team goals to organizational purpose removing barriers to execution and enabling cross functional collaboration.

Responsibilities

Works with the Manufacturing, Quality Control, Materials Management, and Facilities/Engineering departments as a Quality Assurance representative.
Provides oversight of the shift of QA specialists responsible for supporting operations at the site.
Performs apheresis accession of patient material and escalate any nonconformances to the appropriate global teams.
Performs shipment authorization of final product.
Performs the inspection of final product labels to be released for GMP use.
Coordinate and facilitate Quality Assurance (QA) production related activities, including: Review of electronic batch records and manufacturing labels.
On-the-floor quality support to manufacturing and QC staff including real-time review of process comments.
Assessment and closure of laboratory investigations.
Timely assessment and closure of batch and material hold events.
Review of batch manufacturing and testing documentation for timely delivery of final product.
Ensures that tests are performed and products are manufactured in compliance with Kite specifications and regulatory and GMP guidelines.
Supports development of SOPs and reviews/approves SOPs to ensure quality objectives are met.
Reviews and approves test methods, manufacturing/quality control qualification/validation protocols, and reports.
Provides QA support resolving material, in-process product, final product, environmental, facility, and equipment manufacturing issues.
Provides QA oversight for site and network projects.
Provides periodic updates to management for deviations, GMP and system issues, non-conforming materials and products and CAPA.
Additional duties as assigned.
These duties can be delegated to designated deputies of a satisfactory qualification level as needed.