Collaborates to develop, implement, and execute critical cleanroom contamination control strategies such as coordination, scheduling, environmental monitoring (EM), data reporting and analysis, investigation, development, and implementation of corrective action or preventative action (CAPA), project timelines and tasks, and technical and procedural documents. Oversees training and mentoring of staff.
Essential Functions:
- Coordinates to ensure production activities are properly supported. Ensures appropriate environment to prevent interruptions. Schedules and executes routine environmental sampling as necessary, and monitors sample cultures.
- Supports GxP responsibilities. Acts as a liaison to ensure operational goals are performed in an appropriate environment.
- Coordinates and leads daily team activities. Trains new and existing staff and prioritizes in a shifting environment. Anticipates problems and removes obstacles to enable staff to perform tasks as assigned. Mentors and provides professional development to staff.
- Presents quarterly environmental conditions trends and data summaries to BMR management.
- Identifies, initiates, and monitors investigations of adverse environmental conditions and trends. Provides involvement and responsibility in audits and inspection outcomes.
- Performs in accordance with established policies, procedures, and techniques. Develops and enforces procedures and controls. Provides approval of procedures established by junior staff.
Education Requirement: Must possess relevant four-year degree OR relevant experience with a background in the life sciences, biotechnology or gene therapy industries, preferred. Skills:
- Must be able to lead a team while collaborating to manage a variety of responsibilities, including performing the work of the team. Cultivates a diverse and collaborative team environment.
- Excellent interpersonal communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
- Must be proficient in Microsoft Office (PowerPoint, Excel, Word).
- Ability to work independently as well as collaboratively in a diverse and inclusive work environment. Works to specific measurable objectives requiring operational planning skills with little direct supervision.
- Exercises discretion, judgment, and personal responsibility.
- Demonstrates high level of integrity, positivity, and attention to detail. Must have significant latitude for making decisions for unit.
Experience:
- Two years relevant experience (w/4 YR degree) OR four years relevant experience without degree, required.
- Prior supervisory experience, preferred.
- Prior experience handling confidential information and the ability to maintain confidentiality, required.
- Training, common experience, or working knowledge related to the tasks performed, required.
Physical Requirements: OCCASIONALLY: Bend/twist, Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Climb stairs/ladder, Flexing/extending of neck, Hand use: grasping, gripping, turning, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 100 lbs or greater with assistance, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing / Pulling: 61-100 lbs, Reaching above shoulder, Repetitive hand/arm use, Squat/kneel FREQUENTLY: Computer skills, Decision Making, Interpreting Data, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Lifting / Carrying: 41-60 lbs, Problem solving, Sitting, Standing, Walking CONTINUOUSLY: Audible speech, Color vision, Depth perception, Hearing acuity, Peripheral vision, Seeing - Far/near "The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"
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