Supervisor 3rd Shift QC Micro

Profile

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position: Supervisor, QC Microbiology

Manager: Manager, QC Microbiology

Prerequisites: N/A

Location: Phoenix, Arizona

Purpose and Scope of Position

The Supervisor, QC Microbiology is responsible for the supervision of and oversight of the daily shift activities and personnel in the QC Microbiology group as they perform routine and non-routine microbiological testing and environmental monitoring in support of sterile product manufacturing. 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, JP and other regulatory requirements at all times.

Required Competencies: Knowledge, Skills, and Abilities


Intermediate understanding of regulatory filings and their impact to daily operations.
Strong written and effective verbal communication skills.
Intermediate proficiency in MS Word, Outlook, and Excel programs as well as PowerPoint, Project and Visio.
Intermediate ability to interpret / write complex business and technical documents.
Requires strong presentation development and delivery skills.
Ability to deal appropriately with regulatory agencies.
Requires flexibility and ability to multi-task, strong organizational and time management skills.
Advanced knowledge of cGMP, OSHA, DEA, USP, EP, and other regulatory guidance documents.
Advanced critical reasoning and decision-making skills for solving routine and complex problems that impact multiple departments.
Advanced teamwork, facilitation, and training skills, with the ability to develop direct reports/others, delegate and motivate.
Advanced qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility, tolerance, humility/humbleness, hungry and people smart.
Requires a strong ability to cohesively build solid functional working partnerships with other department management with regards to the site's manufacturing obligations.


Duties and Responsibilities

Support QC Microbiology Management:


Assist Senior Department Management with detailed planning and tracking of testing and monitoring events.
Coordinates testing and monitoring activities within the QC lab and manufacturing facility.
Coordinates and communicates with external departments regarding timelines, including attending planning meetings.
Planning and follow up on activities performed by contract testing laboratories.
Ensure proper tracking of non-routine testing events.
Follow up on testing execution with analysts, ensure communication to Laboratory Management.
Responsible for tracking tools (EM batch release, sample trackers, etc.)
Administrative tasks.
Perform approval of laboratory data as required.
Coordinate allocation of shift resources, such as instrumentation and analyst availability.
Assist analysts with questions and troubleshooting.
Communicate effectively with Senior management regarding more complex issues.


Coach, Mentor and Develop, so as to ensure employees are properly trained and qualified:


Train and mentor subordinates and other department analysts.
Teach and train new employees, oversee and conduct microbiological task qualifications.
Provide performance evaluations, support career and individual development plans for direct reports.
Plan and provide oversight for special project work associated with QC Microbiology activities.


Oversee and perform Environmental Monitoring and Microbiology functions:


Oversee and when required, perform functions associated with Environmental Monitoring's sampling/testing processes for the sites Manufacturing Controlled Area Spaces.
Oversee and when required, perform functions associated with Microbiological sampling and testing of plant water and steam systems, microbiological testing of incoming raw materials and components, in process bulk samples, and finished product testing.
Assign weekly job responsibilities to analysts performing routine and non-routine QCMicrobiology/Environmental Monitoring functions and ensure all tasks are performed timely and correctly.
Support Validation department in qualification and re-qualification activities related to depyrogenation, steam sterilization, and disinfectant efficacy studies.
Oversee Quality Control testing for laboratory reagents and microbiological testing media.
Review and approve data generated by Microbiologists and ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU, JP and other regulatory requirements at all times. Record and interprets data results. Ensure all procedures comply with applicable regulatory requirements.


Support Deviations, CAPA, document revisions and department projects:


Serve as author and/or technical reviewer of department operating procedures
Perform assigned tasks within a CAPA, deviation or project.
Utilize scientific principles to assist in troubleshooting and problem solving for microbiology deviations.
Participate in more complex projects and continuous improvement efforts.
Draft, revise and review technical documents, such as SOPs and protocols.
Communicate effectively with Senior management regarding task completion, roadblocks and needs.
Assist in the development and implementation of corrective actions.
Determines impact of changes to QC department and supported GXP computerized systems.


Write and review technical and business documents:


Perform QC Microbiology related Deviation Investigations and Corrective Actions.
Oversee and prepare written QC Microbiology trend reports. Prepare protocol, summary, document change and investigational reports as needed.


Performs other tasks as assigned.

Education and Experience


Bachelor's Degree preferred. Degree preferably in Microbiology or related science.
4 years relevant work experience required, preferably in a pharmaceutical laboratory environment with a working knowledge and experience in Environmental Monitoring, Aseptic Technique, Bioburden testing, Bacterial Endotoxin testing and Sterility testing.
An equivalent combination of education, experience and training may substitute.


Working Conditions


The incumbent may be required to wear uniform/PPE to work in a manufacturing, orlaboratory environment.
The incumbent will be required to type for up to 4 hours per day.
This position requires regular medical surveillance and may require incumbent to wear a respirator or gown.
The incumbent will be required to maintain a safety alertness due to work around hazardous equipment and cytotoxic product.
The incumbent may be required to qualify and maintain Aseptic area gowning qualifications and may be required to participate in annual Aseptic Process Simulation events.


Definitions and Abbreviations


United States Pharmacopeia (USP)
European Union (EU)
Japanese Pharmacopeia (JP)
British Pharmacopeia (BP)
Occupational Safety and Health Administration (OSHA)


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.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1527355_EN

Updated: 2020-07-08 00:00:00.000 UTC

Location: Phoenix,Arizona

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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