QC Manager Microbiology

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.
PURPOSE AND SCOPE OF POSITION: The Manager Quality Control, Microbiology is a full-time position that plays a key role in supporting the objectives of the contamination control strategy at the Manufacturing Plant located in Bothell, WA. The primary focus for this role is the maintenance and continuing improvement of business processes specific to the facility and
serves as the technical lead for evaluation, validation, and implementation of new microbiology methods.
This is an individual contributor position, it does not have direct reports.
MP Environmental Monitoring (EM) and site contamination control programs. This includes EM risk assessment, trending and interpretation of EM data, and oversight of the EM excursion business process. The QC Manager owns or supports investigation and/or change control strategies for processes that impact environmental control. Additionally, this role works closely with stakeholders in manufacturing, engineering, and validation to drive alignment to site contamination control goals and standards. The QC Manager is a Subject Matter Expert for compendial and rapid microbiology laboratory methods.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Education:
- Bachelor's degree, preferably in biology, microbiology, or biochemistry.
Experience
- 8+ years' experience in a cGMP/FDA-regulated environment.
- Experience with application of root cause analysis tools for the purpose of investigation execution.
- Experience and extensive understanding of environmental control regulations and guidelines with in-depth knowledge of cGMPs.
- Experience with Quality Systems (e.g. Document Management System, Quality Management System, Learning Management System, Change Control, Deviations, and CAPA programs).
- Experience in GMP-regulated environment is preferred, working knowledge of cGood Manufacturing Practices (21 CFR 210/211, 600, & 820) and relevant EU GMPs
Knowledge, Skills, and Abilities
- Proven experience working as a detailed-oriented team player with effective planning, organization and execution skills.
- Strong computer skills with MS Office (e.g. Word, Visio and Excel).
- Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
- Innovative, proactive, and resourceful; committed to quality and continuous improvement.
- Proficient in Microsoft Office programs, with advanced/expert proficiency in MS Excel.
- Good interpersonal skills and ability to work with others in a positive, collaborative manner.
- Ability to work independently and perform with a high degree of accuracy.
- Ability to apply FDA Good Manufacturing Practice (cGMP) and relevant EU GMP requirements and guidelines and documentation practices.
DUTIES AND RESPONSIBILITIES:
Key Responsibilities
- Lead planning efforts and develop cross-functional contamination control strategies
- Coordinate, direct and support the activities of cross-functional teams as needed
- Identify, track and facilitate resolution of technical issues impacting contamination control
- Communicate on a regular basis with the project team and senior management regarding project progress, risks, issues and solutions.
- Author technical protocols and reports.
- Ownership of change control records.
- Review and approval of SOPs and/or test method documents as applicable.
- Review and approval of validation documents
WORKING CONDITIONS (US Only):
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.
BMSCART
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1533582
Updated: 2021-05-14 04:07:37.720 UTC
Location: Bothell,Washington
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.