Lead Validation Analyst, QC Laboratory Operations

Company: bluebird bio
Location: Cambridge
Posted on: February 25, 2021

Job Description:

Lead Validation Analyst, QC Laboratory Operations At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We're 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo. Lead Validation Analyst, QC Laboratory Operations ABOUT THE NEST At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We're 1100+ doers, thinkers and collaborators across 7 countries with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our flock and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo. ABOUT THE FLOCK The Quality Control flock is all about enthusiastic collaboration. Whether it's making sure the QC Laboratory is supported with validation and qualification programs, maintaining the validated state of our equipment and instruments, or ensuring compliance and data integrity we are driven by the results we are able to drive in support of our greater goal. Come work with this high-paced group of birds that love rising to the challenge and being apart of something so important. HOW YOU'LL FLY As a Quality Control Validation bird reporting to the Laboratory Operations manager you'll help to bring more patients their bluebird days by:

• Develop, author, and execute internal validation/qualification documentation for analytical instruments/equipment, including URS, IOQ, PQ, RTM, and summary reports.
• Schedule and coordinate validation activities with system owners, vendors, and key stakeholders
• Lead the change-control aspects of validation, ensuring validation impact assessment, procedural impact, regulatory impact, and prescribed testing are adequate and well justified.
• Interface with Validation, Quality Assurance, IT, CSV, System Owners, and key stakeholders to facilitate timely protocol execution and remediate issues during protocol execution.
• Proven capacity to lead cross functional teams.
• Assist with the development and execution of data integrity initiatives in the QC Lab.
• Represent the QC Lab Ops in project teams, audits, and inspections as required
• Support equipment and instruments maintenance, calibration, periodic assessment, equipment alarm monitoring, data integrity and control, cGMP documentation, LIMS, laboratory audits and training.
• Contribute to continuous improvement projects including instrument/equipment validation and data integrity.
• Mentor and assist with developing junior/new staff
• Perform training sessions on QC Lab Op owned procedures to QC staff and external groups, as needed. WHAT YOU'LL BRING You're the bird we're looking for if you:
  • Have a bachelor's degree with 7+ years GMP experience or Master's degree with 3+ years GMP experience. GMP experience is required.
  • Are experienced in validating analytical instrumentation and equipment (e.g. flow cytometers, qPCR, UPLC, automated cell counters, automated DNA extractors, plate readers, plate washers, biosafety Cabinets, refrigerators, LN2, and freezers).
  • Are familiar with cGMP guidelines, ICH Q7, Q8, Q9, Q10, GAMP5 and other international regulatory requirements, or guidance, relevant for equipment/instrument/computer system validation.
  • Have excellent leadership skills to lead cross functional teams to ensure project success. Superb written and verbal communication skills including the ability to communicate, influence and negotiate across the organization. Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
  • A can-do attitude that includes an initiative and ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
  • Are driven to improve processes and work in a collaborative environment to increase efficiency and compliance without sacrificing quality for our patients.-- All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself. bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth. bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics. All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself. bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth. bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics. Will you now or in the future require bluebird bio to commence ("sponsor") an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)? --*
    Point of Data Transfer - GDPR --*
    Your privacy is important to us. bluebird bio, Inc. will use the information provided on this form to evaluate you for the position you are applying for and stay in contact with you for recruiting and hiring purposes. Please take a moment to read the Data Privacy Consent --located here and provide consent to the collection, processing, and notification of your rights regarding your personal information below. For more general information on how we will use, store, and protect the personal information provided through this form and on the website, please read our privacy policy located--here .Read the Data Privacy Consent and select "I accept" to agree to the collection and processing of your personal information. U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at bluebird bio are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Are you Hispanic/Latino? Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
    • Autism
    • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
    • Blind or low vision
    • Cancer
    • Cardiovascular or heart disease
    • Celiac disease
    • Cerebral palsy
    • Deaf or hard of hearing
    • Depression or anxiety
    • Diabetes
    • Epilepsy
    • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
    • Intellectual disability
    • Missing limbs or partially missing limbs
    • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
    • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: bluebird bio, Cambridge , Lead Validation Analyst, QC Laboratory Operations, Healthcare , Cambridge, Massachusetts