Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryReporting to the Quality Manager, the Associate Manager/Staff Quality Scientist II – Microbiology Lab & Sterility Assurance provides direct management of technical staff.
The role contributes to setting the tactics required to achieve departmental and plant/business objectives. Through outstanding communication; effective problem solving and active management of ambiguous situations; the Associate Manager ensures product safety, product quality and compliance with all relevant global regulations and customer expectations.
Success is measured in terms of the frequency and scale of product quality and organizational issues. Through stakeholder engagement; and people development; the Associate Manager produces durable and industry leading results supporting key business drivers.
- Performs tasks, of moderate complexity, within planned schedules and timelines, supporting audits (FDA, ISO, Customer, Internal, etc.), actively leading or participating on project teams, ensuring documentation/procedural compliance and revises policies/procedures as required.
- Conducts and/or coordinates microbiological & sterility assurance tasks associated with the manufacturing and sterilization of medical devices.
- Coordinates the collection and analysis of test samples.
- Supervises Sterility Assurance and Contamination Control Programs.
- Monitors production environment, processes and personnel for microbial and particulate contamination.
- Provides microbiological guidance to manufacturing.
- Writes and modifies (when required) procedures, protocols relative to microbiological and sterilization programs.
- Develops, implements, and reviews procedures and protocols to assure compliance with internal and external regulatory agencies.
- Analyze and trend data and organize into reports and present data, trends and recommendations for improvement.
- Performs/manages routine preventative maintenance/monitoring of laboratory equipment/supplies.
- Releases product for distribution, resolves non-conformances or deviations as they occur.
- Supervises the activities of the Microbiology Lab and Sterility Assurance personnel.
- Manages and monitors the department budget including laboratory supplies and equipment.
- Works with change control requesters to determine change implementation strategies and provides input, writes/updates procedures/protocols relative to microbiological and sterilization programs. This includes work with Process Validation, Experimental Work Orders (EWO), Process Change Request Forms (PCRF), etc.
- Comply with all local, state, federal, and BD safety regulations, policies, and procedures including RCRA Hazardous Waste regulations. Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
- Other duties as assigned.
Essential Functions Preferred
- Manages, occasionally through subordinate supervisors, the coordination of the activities within the Microbiology Lab and Sterility Assurance teams, with responsibility for results, including costs, methods, and talent management.
- This position is accountable for working with internal and external customers and vendors to ensure compliance with Regulatory Standards. Most information used/gathered is company confidential.
- Manages External Standards pertaining to the Microbiology Lab and Electron Beam (E-Beam) Sterilization of medical devices.
- Coordinate and manage support activities with other BD Businesses to provide Microbiology Lab and Sterility Assurance services (testing, sterility release, consultation, etc.). Manage financial budget for these activities.
Required Skills and Knowledge
- Strong verbal, technical writing, analytical and interpersonal skills.
- Working knowledge of statistical tools.
- Working knowledge of Internal and ISO regulations and standards.
- Limited knowledge of applicable Regulatory, Corporate and/or Unit requirements.
- A minimum of 5 years industrial experience with increasingly responsible positions in Microbiology Lab in a medical device manufacturing environment.
- Attention to detail, careful, deliberate, disciplined, meticulous.
- Effective organizational and planning skills.
- Analytical skills and strong problem-solving abilities.
- Excellent written and oral communication skills.
Technical Area of Expertise
- Knowledge of FDA/ISO regulations related to the Microbiology Lab in support of the manufacture of medical devices is highly desired.
- Responsible for the supervision of the Microbiology Lab associates.
- Works independently with internal and external customers and vendors.
- Responsible for information collected to ensure compliance with Regulatory Standards.
- Accountable for accurate and timely work.
- Responsible for supporting audits – internal and external.
- BA/BS Degree (Major: B.S. Microbiology or Biological Sciences or related discipline)
- Minimum of 3 years of experience in ISO / FDA regulated environments related to a Microbiology Lab in support of the manufacture of medical devices is highly desired. Exposure to medical product sterilization processes (ideally E-Beam) is a plus.
- 3+ yr. Experience in ISO / FDA regulated environments related to a Microbiology Lab in support of the manufacture of medical devices is highly desired. Exposure to medical product sterilization processes (ideally E-Beam) is a plus.
- 3+ yr. experience supervision of Microbiology Lab department.
- 3+ yr. experience representing a manufacturing plant in a global corporate environment is preferred.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationUSA CT - Canaan
Work ShiftUS BD 1st Shift 8am-5pm (United States of America)
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve.
Senior Director Quality Management
To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.
It is inspiring to see BD products to be used globally to advance human healthcare.
Manager Medical Laboratory