QA Specialist – III
Website Leadstack Inc
Company : Leadstack Inc
Country: United States
Location : Santa Monica, California
Post: Fri, 09 Sep 2022 15:29:06 GMT
Expires: Fri, 07 Oct 2022 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
Senior Quality Assurance Specialist III
Duration: 6 months
Location: Santa Monica, CA
We are seeking a highly motivated individual to join us as a Quality Assurance Specialist III. Reporting to the Sr Manager of Global Quality Assurance for Raw Materials and Reagents Center of Excellence, you will assist with managing the activities of the Quality Assurance department and supervise quality assurance efforts to ensure conformance to Kite Pharma quality standards and government regulations.
The Quality Assurance Specialist III 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 practices and be accountable for managing the QA projects and timelines. This role is accountable for Quality Assurance responsibilities related to the disposition of raw materials globally on behalf of Kite Pharma.
Responsibilities (include but are not limited to):
Work closely with and provide quality oversight across functions (across network site QA, Global RM and Regents QC and Tech Excellence, Supply Chain, SQM, Process Development, Regulatory Affairs, Manufacturing) within Kite and externally to assure compliance and strong relationships
Support strong partnership with network wide site QA groups to ensure global RM and Regents QA operations are continuously improved
Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements including but not limited to:
RM documentation review and ensure resolution of issues to release raw materials
Review and approval of raw material OOS, Deviations and CAPAs
Disposition of raw materials lot
Review and approval of Change Controls and ensure proper maintenance and approval of cGMP documents. Ensure change controls are initiated, evaluated and implemented appropriately for all regulated changes.
Support quality walk through of QC lab
Support regulatory inspections, internal audits, and external audits from partners
Acts as an Analytical QA subject matter expert in support of regulatory inspections and internal audits.
May conduct or serve as a lead/coordinator of investigations and corrective/preventative actions
Review and approval of technical (analytical) and validation protocols and reports as appropriate.
Reviews and approves analytical validation efforts from phase 1 through commercial and experienced in method validation and method transfer guidelines per ICH and USP.
Serves as QA project lead, leads complex quality investigations/deviations, and independently authors or approves concise quality investigation reports with appropriate corrective action and preventive actions (CAPA).
Participate in Material Review Board meetings to ensure non-conforming material is appropriately dispositioned.
Support Quality Management Review activities and oversee trending of key quality, raw material and GMP metrics
Provide QA consultations to support QC on the floor process.
Up to 10% domestic travel
Perform other duties as assigned
5+ years of experience in a GMP environment with BS degree in the biological sciences or related field
3+ years of experience in a GMP environment with MS degree in the biological sciences or related field
In-depth knowledge of and ability to apply GMP in conformance to US, EU and ROW standards
Proficient in cGMP regulations, quality systems and regulatory requirements.
Experience writing, evaluating and closing investigations, CAPAs and change control records.
Experience with conducting and managing internal and external audits.
In-depth understanding and application of qualification and validation principles, concepts, practices, and standards.
Ability to effectively negotiate and build collaboration amongst individuals.
Proficient in MS Word, Excel, Power Point and other applications.
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
Willingness to think outside of the box and adapt best practices to a growing environment
Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
Possess critical thinking skills when making sound quality decisions based on risk management and available data.
Ability to recognize deviations from accepted practice and apply knowledge of current Good Manufacturing Practices (CGMP) on a daily basis.
Advanced technical writing and excel skills are highly desired for creating and presenting reports.
Ability to work independently and effectively coach peers in a high-paced environment with tight timelines, while maintaining accuracy and quality.
Ability to effectively generate metrics, and present; data, findings, and improvement initiatives/projects to QA and cross-functional leadership. “
A relevant background in Quality Control or Analytical Development with a role as a supervisor or manager is highly desired
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