Quality Control Manager

Fred Hutchinson Cancer Research Center Seattle , WA 98113

Posted 1 week ago

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Fred Hutch Quality Control (QC) department performs in-process and release testing assays for a wide range of Phase I/II clinical products manufactured in both the Cellular Processing Facility (CPF) and the Biologics Production Facility (BPF). Products range from autologous T-Cell therapies (CAR-T, T-Cell Receptors, and Tumor-Infiltrating Lymphocytes) to complex biological products including lentiviral vectors, fusion proteins and monoclonal antibodies. The team also qualifies test methods and equipment to support these activities and actively supports regulatory submissions.

Responsibilities

The Quality Control Manager reporting to the Head of Quality for the Therapeutics Product Program (TPP) will support the Phase I/II Cell Processing Facility (CPF) and Biologics Production Facility (BPF) operations. The QC Manager will interact with manufacturing personnel in the BPF and CPF, research scientists, physician investigators, Process Development, Quality Assurance and other scientific staff and external collaborators.

  • Lead and champion quality control system integration between the Cellular Processing and the Biologics Production facilities

  • Integrate the quality control role into the BPF organization

  • Champion proactive identification and resolution of compliance gaps

  • Create quality control programs as required

  • Provide quality control support to multiple areas within both manufacturing facilities

  • Support facility improvement projects

  • Ensure management and control of critical equipment within the QC laboratories

  • Aid in the enhancement of the Environmental Monitoring programs

  • Oversee the implementation and continual improvement of the QC systems.

  • Define and report on performance metrics measuring lab quality. Advises staff on areas for improvement, QC focus areas and efficiency in the quality control process.

  • Oversees the effective training of staff within the QC department. Prepare written procedures and training material.

  • Act as subject matter expert for Out of Specification investigations. Serves as lead for discussions regarding QC testing or investigations as they relate to clinical studies.

  • Responsible for personnel management of quality control associates inclusive of personnel scheduling, time management, performance management and ensuring career development opportunities in order to encourage employee retention.

Qualifications

Required Skills:

  • BS or MS in Biology or related discipline.

  • Experience working in a regulated GMP environment.

  • Minimum of 5 years working in a quality role within a cellular therapy or biopharmaceutical organization.

  • Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.

  • Ability to manage conflict.

  • Ability to work as a team member and to work collaboratively with strong listening skills.

  • Ability to translate strategic initiatives into tactical solutions.

  • Must be knowledgeable of FDA cGMP regulations and guidelines.

Preferred Skills:

  • Ability to utilize elements of Quality Risk Management to manage and control risk.

  • Ability to effectively present complex data and strategy to large groups.

  • Proven track record in developing or leading teams.

  • Experience with flow cytometry, cell culture based functional assays (e.g. target cell killing, RT-PCR, ELISA, etc.).

  • Expertise in qualification and validation of analytical methods and equipment under FDA/ICH guidelines.

  • Experience generating documents intended for use in a GxP environment or regulatory filings inclusive of DMF, IND and/or CMC.

  • Familiarity with data analysis/statistical software packages (e.g. FlowJo, Gen5, JMP, etc) desirable, but not required.

Our Commitment to DiversityWe are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Quality Control Manager

Doyon

Posted 3 days ago

VIEW JOBS 3/22/2019 12:00:00 AM 2019-06-20T00:00 Apply On-line Title Quality Control Manager Job Reference 19-0086 Post Date 3/22/2019 CARC Yes City/Location Lanham State MD Point of Hire Seattle, WA Company DMS - Doyon Management Services, LLC Reports To Project Manager Type of Position Regular Full-Time FLSA Status Exempt Schedule Varies Description JOB SUMMARY: The Quality Control Manager (QCM) has overall responsibility for reporting directly to the Project Manager and Corporate Management for the verification that we meet all quality standards on our projects. The Quality Control Manager (project level) plans, coordinates, and oversees implementation of Construction quality control and quality assurance programs at the project level. This position also creates, reviews and amends Project Quality Plans to keep them current and to ensure compliance in all respects with the contract, established standards, methods and specifications. ESSENTIAL FUNCTIONS: * Create and manage the Quality Control Plan for success on assigned construction projects * Read and understand complex contract specifications, documents and architectural/engineering/mechanical and electrical drawings * Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables * Define problems, collect data, establish facts, and draw valid conclusions * Review and approve submittals, process and understand RFI's * Create a Daily Activity Report to be a detailed, thorough and complete historical record of the days daily activities * Work with others in a team environment to ensure contract requirements, project goals and objectives are met * Communicate and reason with client's quality assurance personnel, designers, technical experts, subcontractors and owners, and field quality assurance, technical authorities and construction supervisory representatives * Make presentations, host meetings and engage in problem solving by bringing together technical experts, authorities having jurisdiction, assigning action items, documenting minutes and follow through to closure * Proficiency in QCS/RMS software applications, Word, Excel, and Outlook * Prepare graphs, charts of data, proposals, reports, and manuals * Implement the three phases of quality control * Take and read survey shots (grade and elevation) * Mentor Quality Control Specialists and Quality Control Managers I * Other duties as assigned SUPERVISORY RESPONSIBILITIES: * Depending on size, complexity and number of Definable Features of Work, this position manages the Project Quality Control Plan, ensures all contract requirements are being met and supervises project Quality Control Inspectors. CORE COMPETENCIES: * Commitment to Excellence - Identifies what needs to be accomplished and takes action to achieve a standard of excellence beyond job expectations * Corporate Values - Understands, embraces, and integrates Doyon corporate values into everyday duties and responsibilities * Customer Service - Identifies and responds to current and future needs by providing excellent service to internal and external customers * Safety and Security - Promotes a safe work environment for co-workers and customers * Teamwork - Resourceful team player that builds, strengthens, and maintains collaborative relationships with others inside or outside the organization JOB SPECIFIC COMPETENCIES: * Attention to Detail- Ensures one's own and other's work and information are complete and accurate * Planning and Organizing- Systematically develop plans, prioritize, organize and manage resources in order to accomplish business goals within a specific period of time Requirements QUALIFICATIONS: Required: * • Bachelor's degree in Construction Management, Engineering or related field or an equivalent combination of education and experience * Minimum of 15 years' experience in construction management-preferably in the federal arena * Specific past performance and references as an approved QC Manager on multiple Federal construction projects * Contractor Quality Management for Contractors Certification or ability to obtain the certification * Experience overseeing multiple projects simultaneously * Strong proficiency in QCS/RMS software applications, Internet and Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) Preferred: * Valid OSHA 10/30 certification * Valid First Aid/CPR certification * Leadership in Energy & Environmental Design (LEED) certification WORKING ENVIRONMENT: The majority of the work is performed in an indoor/outdoor setting with a wide variety of people in differing functions, personalities and abilities. PHYSICAL DEMANDS: An individual will be required to perform climbing, balancing, stooping, kneeling, standing, walking, pushing, pulling, lifting, finger, grasp, feel, talk, hear and repeat motions. Light Work: Exerting up to 40 pounds of force occasionally, and /or up to 15 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects is required. The employee is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; viewing a computer terminal; reading; visual inspection involving small defects, small parts and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes. Occasional travel. REASONABLE ACCOMMODATION: It is Doyon's business philosophy and practice to provide reasonable accommodations, according to applicable state and federal laws, to all qualified individuals with physical or mental disabilities. PREFERENCE STATEMENT: Doyon grants preference to qualified Doyon Shareholders first, and second to qualified shareholders of other Alaska Native corporations that grant a similar preference in all phases of employment and training, which include, but are not limited to hiring, promotion, layoff, transfer, and training. This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. We are a Federal Contractor and comply with the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA). We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity or national origin, disability, veteran status, and other protected characteristics. The EEO is the Law and the poster is available at http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf. For questions on the job posting contact (253) 344-5300. * Except as provided otherwise under applicable law, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans. * Please view Equal Employment Opportunity Posters provided by OFCCP here. Apply On-line Send This Job to a Friend * Contact Us * Sitemap * Privacy Policy © Doyon Limited. Doyon Seattle WA

Quality Control Manager

Fred Hutchinson Cancer Research Center