Coordinator, Quality Assurance Document Control at Celgene

Expires in 4 days

Phoenix, Arizona Req #: 1902761
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 QA Document Control Coordinator administers elements of the site Document Change Control
process which include reviewing, approving, reporting on, and monitoring GMP documents in the
document management system. Uses manual and electronic document management tools and
systems to perform document change control duties. Under general supervision, develops
Standard Operating Procedures (SOPs) and forms for areas of expertise within the QA Document
Control group. Works and interacts with other departments on a routine basis.
Required Competencies: Knowledge, Skills, and Abilities
 Ability to properly communicate e-mails and routine business matters with management with
high level of accuracy.
 Basic computer skills and ability to retrieve and input data.
 Basic writing skills and ability to follow technical reports.
 Must be action-oriented and customer-focused and possess learning agility.
 Ability to learn from mistakes and actively listen
 Basic proficiency in MS Word, Outlook, Excel
 Ability to deal appropriately with regulatory agencies
 Basic knowledge of cGMP, OSHA, DEA, USP and EP
 Requires flexibility and ability to multi-task
 Requires strong written and verbal communication skills
 Ability to interpret / write general business documents
 Ability to solve routine problems
 Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity,
honesty, flexibility and tolerance

Duties and Responsibilities

Performs routine documentation related activities.
 Processes and implements GMP document revisions; prepares document drafts and final
masters per approved document change controls; reviews document change packages
submitted to assure all required documents are complete and present; initiates workflow
routings as needed, schedules and implements approved changes; notifies appropriate
personnel of new, revised and obsolete documentation.
 Assists end user in creation of documents and formatting as requested.
 Monitors controlled document periodic review process and send notifications as applicable.
 Creates, maintains and/or verifies learning management system records associated with
implemented controlled documentation.
 Revises or creates SOPs, forms and document change controls relating to departmental
subject matter.
Performs activities related to maintaining and filing of documentation.
 Maintains electronic master document files in orderly manner.
 Maintains current master hard-copy and history documentation files as defined in departmental
SOPs.
 Coordinates and maintains controlled documentation received from other departments or from
outside the site; administers and monitors site approval process as needed.
Performs other duties and special projects as assigned.

Education and Experience

 Bachelor’s degree preferred
 2 years’ relevant work experience required, preferably in Quality Assurance and/or Quality
Control in a regulated setting
 An equivalent combination of education, experience and training may substitute.

Working Conditions

Work is performed in a typical office environment, with standard office equipment available and
used. Work is generally performed seated, but may require standing and walking for up to 10% of
the time. Lighting and temperature are adequate and there are no abnormal conditions caused by
noise, dust, etc.

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.

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