Specialist, Quality E-Systems

Celgene Corporation Phoenix , AZ 85002

Posted 2 months ago

Job Description:

Req #: 1902829

Location: Phoenix, Arizona, United States

Job Category: Quality

Work Location: 620 N. 51st Avenue 85043

Organization: Quality Operations

Employee Status: Full-time

Job Type: Regular

Purpose and Scope of Position

The Specialist, QA eSystems' primary responsibility is to help assure the quality, integrity, and compliance of site Information Technology (IT) systems, and maintain alignment between business process owners, end users, and other cross functional areas. Altogether, the Specialist will help ensure that IT systems are designed, setup, and function in a GMP-compliant manner which, in turn, will assist the site in safeguarding and maintaining the safety and quality of Celgene's products.

Required Competencies: Knowledge, Skills, and Abilities

  • Intermediate knowledge of GMP guidance and regulations, including those pertaining to computerized system design, function, and use.

  • Intermediate knowledge of Microsoft Word, Outlook, and Excel.

  • Requires ability to communicate appropriately with regulatory agencies

  • Intermediate written and verbal communication skills.

  • Intermediate problem-solving, critical-reasoning, and decision-making skills.

  • Intermediate time-management, organizational, and multi-tasking abilities.

Duties and Responsibilities

Maintain the quality, integrity, and compliance of company IT systems in order to help assure the safety and quality of Celgene products.

  • Provides input and quality approvals for validation documentation that supports enterprise systems or applicable site owned systems.

  • Provides quality approvals for audit trails related to batch release and periodic review

  • Drives use of best-practices during IT systems design, validation, and use.

  • Collaborates with business stakeholders, technical support groups and Quality Assurance (as needed) to thoroughly investigate validation or engineering discrepancies.

  • Ensures all required system documentation is maintained as changes in the system(s) are made. Documentation includes but not limited to functional requirements, user requirements, and design specifications.

  • Reviews and approves documents, change controls, and protocols related to IT systems.

  • Supports deviations as needed.

Represents and leads Phoenix Quality Operations through the initiation and implementation of projects related to electronic systems.

  • Manages project activities and ensures appropriate team members are assigned to appropriate activities.

  • Supports continual alignment of the business process with other business functions and provide effective on-going end user support.

  • Develops, maintains and improves key business processes.

  • Drafts, reviews, and edits SOPs, process flow and other business documentation.

  • Performs all other tasks as assigned.

Education and Experience

  • Bachelor's degree preferred, preferably in Science or Engineering.

  • 4 years' relevant work experience required from within a regulated pharmaceutical environment.

  • Experience working in Quality and/or Manufacturing is required.

  • Strong knowledge in Computer Systems Validation (CSV) is required.

  • An equivalent combination of education, experience and training may substitute.

Definitions and Abbreviations

  • GMP: Good Manufacturing Practices
  • IT: Information Technology
  • SOP: Standard Operating Procedure

#LI-POST

About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.


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 Specialist Laboratory Medicine & Pathology

Mayo Clinic

Posted 1 week ago

VIEW JOBS 9/14/2019 12:00:00 AM 2019-12-13T00:00 City Phoenix State Arizona Telecommute No Department Laboratory Medicine & Pathology Why Mayo Clinic Seeking an individual who desires to be part of the Mayo Clinic team, helping ensure our patients receive the highest quality care. The Department of Laboratory Medicine and Pathology is looking for a Quality Specialist to collaborate with our Transfusion Service and other departments within Laboratory Medicine. The ideal candidate has blood banking experience, a bachelor of science degree and at least two years clinical lab experience. Specialist in Blood Banking certification is also preferred. The Quality Specialist works in collaboration with departments assisting with (but not limited to) quality monitoring, process improvements, quality control review, internal and external assessments, proficiency testing and quality committees. Recently Mayo clinic Arizona was rated as the #1 hospital in Arizona for the 7th consecutive year and ranked No. 18 on the Best Hospitals Honor Roll by U.S. News. Position description Collects, prepares, and analyzes monthly departmental monitors. Coordinates and documents proficiency testing activities. Contributes content to Performance Improvement Committees and Transfusion Committee Assists with internal and external audits. Assists in development, coordination, and documentation of Quality System Essential Program. Coordinates department improvement projects. Qualifications Bachelor of science degree. Minimum two years of medical laboratory experience. Additional qualifications * Prefer Specialist in Blood Banking Certification Strong organizational skills and extensive experience with databases Experience as a Medical Technologist with certification from ASCP or AMT, or a related specialty preferred * Strong written, verbal, and interpersonal communication skills. Strong organizational skills and self-initiative. Patience and the ability to effectively coach and mentor others. Familiarity with personal computers for word processing, spreadsheet preparation, data collection/management/analysis, and creation of graphs/charts and presentation slides. Ability to work as a team member, take direction from others, and initiate and manage projects. Familiarity with quality tools such as LEAN, Six Sigma, DMAIC, etc. Working knowledge of laboratory safety and regulatory compliance. Ability to facilitate meetings as required. Exemption status Exempt Compensation Detail Education, experience and tenure may be considered along with internal equity when job offers are extended. The minimum salary every 2 weeks is approx $2,420.00, based on a full-time position. Benefits eligible Yes Schedule Full Time Hours / Pay period 80 Schedule details Monday through Friday, 8am-430pm, occasional weekends may be required. Weekend schedule Occasional, as needed Site description Mayo Clinic's campuses in Arizona are located in Phoenix and Scottsdale, in the beautiful Sonoran Desert. The region is known as the Valley of the Sun, a metropolitan area with more than 4 million residents in 25 cities and towns. With Phoenix being the sixth largest city in the nation, this sunny "desert metropolis" offers the amenities of a big city in the midst of a strikingly beautiful, rugged, southwest landscape. Scottsdale frequently earns praise as a highly desirable place to live. The city's more than 200,000 residents enjoy a vibrant mix of culinary hot spots, arts and entertainment, professional and collegiate sports teams, and community resources. The region's desert climate promotes an outdoor lifestyle with a full complement of sports and recreation. Category Clinical Labs and Research Career profile Clinical Labs Job posting number 120455BR Recruiter Frank Harris Equal opportunity employer Mayo Clinic is an equal opportunity educator and employer (including veterans and persons with disabilities). Mayo Clinic Phoenix AZ

Specialist, Quality E-Systems

Celgene Corporation