BD (Becton, Dickinson and Company) Associate Manager/Staff Quality Scientist II in Canaan, Connecticut
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.
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.
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.
BA/BS Degree (Major:B.S. Microbiology or Biological Sciencesor related discipline)
3+ yr. experience in ISO / FDA regulated medical device industry, with exposure to medical product sterilization processes (E-Beam is a plus).
3+ yr. experience supervision of Microbiology Lab and/or Sterility Assurance departments.
Additional Skills and Qualifications
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 and/or Sterilization.
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 and various modes of medical device sterilization, with Electron Beam (E-Beam) Sterilization of medical devices desired.
Responsible for the supervision of the Microbiology Lab and Sterility Assurance 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.
Required to calculate doses, resolve non-conforming issues and release product.
Responsible for supporting audits – internal and external.
Primary Work LocationUSA CT - Canaan
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