Supervisor, QC Microbiology

Employer
Celgene
Location
Phoenix, Arizona, United States
Posted
Jan 11, 2019
Ref
1804620
Required Education
Bachelors Degree
Position Type
Full time
Req #: 1804620
Location: Phoenix, Arizona, United States
Job Category: Quality
Work Location: 620 N. 51st Avenue 85043
Organization: Quality Control
Employee Status: Full-time
Job Type: Regular

SUPERVISOR, QC MICROBIOLOGY (ENVIRONMENTAL CONTROL)
Phoenix, AZ

Purpose and Scope of Position:
The Supervisor, QC Microbiology Environmental Control supervises and oversees the activities and personnel in the Environmental Control group as they perform routine and non-routine microbiological testing in support of sterile product manufacturing. Trends results within a lab environmental, reviews documents, trains company personnel, writes procedures, protocols, investigations and CAPA's. This includes carrying out responsibilities independently in accordance with the organization's policies, procedures, and state, federal and local laws and ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other regulatory requirements at all times.

Required Competencies: Knowledge, Skills, and Abilities:
  • Ability to deal appropriately with Regulatory agencies.
  • Flexibility and ability to multi-task.
  • Advanced knowledge of current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements.
  • Advanced knowledge of OSHA and DEA.
  • Advanced written skills, ability to interpret and write complex documents.
  • Advanced communication skills.
  • Advanced MS Word, Outlook, Excel, MS PowerPoint, Visio.
  • Advanced problem Solving skills.
  • Strong organization and time management.
  • Strong critical reasoning and decision making.
  • Strong teamwork and facilitation skills.
  • Able to develop and motivate others delegate and solve routine problems.
  • Ability to gown and maintain a sterile work environment.
  • Ability to pass an initial full physical with annual monitoring.

Duties and Responsibilities:

Ensure employees are properly trained and qualified.
  • Train and mentor subordinates and other department analysts.
  • Provide performance evaluations and support career development of direct reports.
  • Participates in aseptic process qualifications: Aseptic gowning, Media fills.
  • Documents, Tracks, and Trends test results:

Performs review of critical cGMP documents supporting batch release and controlled area status.
  • Creates, maintains, and delivers controlled and aseptic area training modules.
  • Serve as author and/or technical reviewer of department operating procedures.
  • Oversee and prepare written monthly/yearly QC Microbiology environmental trend reports. Prepare protocol, summary, document change and investigational reports as needed.
  • Assign weekly job responsibilities to analysts performing routine and non-routine environmental control functions and ensure all tasks are performed timely and correctly.
  • Utilize scientific principles to assist in troubleshooting and problem solving for EC microbiology deviations.

Lab Duties:
  • Perform Media Fill Growth Promotion.
  • Plans and develops special project work.
  • Perform microbial isolation techniques and perform Gram stain identifications.
  • Initiate and performs Deviation Investigations/CAPA's associated with Microbiological testing.

Act as liaison with other departments by representing QC Microbiology at cross functional team meetings.
  • Write and review Technical and business documents.
  • Effectively communicates with department management and cross-functional management.
  • Perform QC Microbiology related Deviation Investigations and Corrective Actions.
  • Serve as author and/or technical reviewer of department operating procedures.
  • Oversee and prepare written monthly/yearly QC Microbiology environmental trend reports.
  • Prepare protocol, summary, document change and investigational reports as needed.
  • Perform other duties as assigned.

Education and Experience:
  • Bachelor's degree preferred, preferably in Microbiology or related science.
  • 4 years' relevant work experience required, preferably in a Pharmaceutical manufacturing environment with cGMP requirements.
  • An equivalent combination of experience/education is acceptable.

Working Conditions:
  • This position involves being fully gowned for extended periods of time within a restrictive movement environment. This may include standing, bending, reaching, kneeling, balancing, pushing, pulling, lifting (NMT 25lb), or carrying (NMT 25lb).
  • This may also include concentrating, remembering names, effective verbal and/or written communication, analytical thinking, decision making, and adapting to change.
  • This position involves working conditions with constricted personnel movements for up to 2 hours a day.
  • This position works within controlled environments with strict gown and gloves requirements.
  • Requires >10% of the time travel for growth improvements.
  • Will be required to wear uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment.
  • Will be required to properly handle cytotoxic materials.

Definitions and Abbreviations:
  • United States Pharmacopeia (USP)
  • European Union (EU)
  • Japanese Pharmacopeia (JP)
  • British Pharmacopeia (BP)
  • Occupational Safety and Health Administration (OSHA)
  • US Drug Enforcement Administration (DEA)
  • Personnel Protective Equipment (PPE)

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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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.