BD (Becton, Dickinson and Company) Associate Manager/Staff Quality Scientist II in Canaan, Connecticut
Job Description SummaryReporting to the Senior Quality Manager, the Quality Manager/Staff Quality Scientist II – Microbiology Lab 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 Quality 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 Quality 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 tasks associated with the manufacturing of medical devices.
Coordinates the collection and analysis of test samples.
Supervises the Microlab in performance of facility Environmental 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 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 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 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.
Preferred Essential Functions
Manages, occasionally through subordinate supervisors, the coordination of the activities within the Microbiology Lab team, 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.
Coordinate and manage support activities with other BD Businesses to provide Microbiology Lab services (testing, consultation, etc.). Manage financial budget for these activities.
BA/BS Degree (Major:B.S. Microbiology or Biological Sciencesor related discipline)
3+ years experience in ISO / FDA regulated environmentsrelated to a Microbiology Lab. (Support of the manufacture of medical devices is highly desired.)
3+ yr. experience supervision of Microbiology Lab department.
Additional Skills and Qualifications
5 years industrial experience with increasingly responsible positions in Microbiology in a medical device environment.
Exposure to medical product sterilization processes (ideally E-Beam) is a plus.
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
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.
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, affectation or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
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, or any other protected status.