Senior Lab Supervisor - System One
Santa Clara, CA
About the Job
Job Title : Senior Lab Supervisor
Location : Santa Clara, CA
Pay Range: $39.00 – 50.00/hr
Type: Contract, Potential for extension or conversion to permanent
Overview
Ensures the safety, compliance, and smooth operations of research and development laboratories associated with the team. Regulates and maintains the infrastructure of the labs to ensure necessary services are available to scientists. Oversees/coordinates work processes and operation of assigned laboratory areas to ensure Quality System compliance, Safety compliance, and proper equipment management. Ensures decisions involving Research and Development labs and equipment do not adversely impact work areas or project teams. Represents Lab Management team as a subject matter expert regarding lab/equipment issues and builds professional relationships with cross-functional teams. Communicates with lab and equipment users and process stakeholders.
Responsibilities
+ Generates or modifies Development Laboratory Management related processes (e.g., Guidance Documents, SOPs). Develop or revise comprehensive documentation that meets organizational standards by writing user-friendly content that meets the needs of target audience, turning insights into language for user success. Review, revise, consolidate and/or retire documents to align with QMS, local procedures and/or best practices.
+ Reviews revisions to existing procedures or new draft procedures with stakeholders, including Quality, and facilitates a Change Request (if needed)
+ Manages, oversees, and authorizes the use of designated laboratory areas with regard to general lab operations (orientation, use, access, general supply replenishment, equipment, cleaning, & maintenance), regulatory compliance (documentation, temperature monitoring) and general safety operations.
+ Enforces Safety and other required laboratory practices, with the independent authority to deny lab users room access, impose re-orientation, and contact users supervisor if necessary. Mediates Lab User conflicts with the authority to escalate issues to direct supervisors.
+ Manages lab documentation to ensure Quality, Safety and departmental compliance. Reviews and ensures equipment/instrumentation documentation (log sheets, chart recorders) is compliant with Good Documentation Practices.
+ Resolves documentation issues with equipment users.
+ Acts and serves as point of contact with department scientific staff and cross-functionally with Subject Matter Experts in Calibration/Facilities to ensure minimal impact to Development project teams during installation, calibration and validation of new equipment.
+ Coordinates calibration, certification, relocation and repair of existing equipment with Instrument /Facilities/Calibration team to minimize impact on project teams needing access to equipment.
+ Participates in a weekly rotating 27/4 on-call CTU service (when alerted for a temperature excursion) with the other Lab Supervisors. Responsibilities include inhibiting alarms in the CTU monitoring software and coming on-site to relocate contents from the failing CTU to a back-up CTU within the allowable timeframe (2 hours or 5 hours) for the type of CTU.
+ Mentors/coaches other Lab Supervisors, provides training and seeks opportunities to develop skills.
+ Other duties as assigned by management.
Requirements
Education:
+ Bachelor's Degree - Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work-experience.
Experience:
+ 3-4 years Relevant industry experience working in an IVD GLP/ISO regulated laboratory environment. (required)
+ 5+ years Relevant industry experience. Experience in audits, knowledgeable in requirements and controls for IVD product development lab, (e.g. ISO 13485, GLP, GDP) or similar regulated lab environment. (preferred)
Knowledge, Skill or Ability Requirements:
+ Possesses excellent people skills with ability to collaborate and build effective internal/cross-functional relationships.
+ Strong desire to work in a highly regulated environment, with diligent attention to detail to ensure Development laboratory areas meet regulatory, departmental, and safety requirements.
+ Willingness to take on new challenges, perform additional tasks when necessary, and work at other RSS sites if necessary to meet Research & Development needs and support business goals.
+ Experience as an effective technical writer with a proven ability to quickly learn and understand complex subject matter with a keen eye for detail. Experience in writing and/or revising documentation and procedures for various audiences. Excellent written and verbal communication skills.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Location : Santa Clara, CA
Pay Range: $39.00 – 50.00/hr
Type: Contract, Potential for extension or conversion to permanent
Overview
Ensures the safety, compliance, and smooth operations of research and development laboratories associated with the team. Regulates and maintains the infrastructure of the labs to ensure necessary services are available to scientists. Oversees/coordinates work processes and operation of assigned laboratory areas to ensure Quality System compliance, Safety compliance, and proper equipment management. Ensures decisions involving Research and Development labs and equipment do not adversely impact work areas or project teams. Represents Lab Management team as a subject matter expert regarding lab/equipment issues and builds professional relationships with cross-functional teams. Communicates with lab and equipment users and process stakeholders.
Responsibilities
+ Generates or modifies Development Laboratory Management related processes (e.g., Guidance Documents, SOPs). Develop or revise comprehensive documentation that meets organizational standards by writing user-friendly content that meets the needs of target audience, turning insights into language for user success. Review, revise, consolidate and/or retire documents to align with QMS, local procedures and/or best practices.
+ Reviews revisions to existing procedures or new draft procedures with stakeholders, including Quality, and facilitates a Change Request (if needed)
+ Manages, oversees, and authorizes the use of designated laboratory areas with regard to general lab operations (orientation, use, access, general supply replenishment, equipment, cleaning, & maintenance), regulatory compliance (documentation, temperature monitoring) and general safety operations.
+ Enforces Safety and other required laboratory practices, with the independent authority to deny lab users room access, impose re-orientation, and contact users supervisor if necessary. Mediates Lab User conflicts with the authority to escalate issues to direct supervisors.
+ Manages lab documentation to ensure Quality, Safety and departmental compliance. Reviews and ensures equipment/instrumentation documentation (log sheets, chart recorders) is compliant with Good Documentation Practices.
+ Resolves documentation issues with equipment users.
+ Acts and serves as point of contact with department scientific staff and cross-functionally with Subject Matter Experts in Calibration/Facilities to ensure minimal impact to Development project teams during installation, calibration and validation of new equipment.
+ Coordinates calibration, certification, relocation and repair of existing equipment with Instrument /Facilities/Calibration team to minimize impact on project teams needing access to equipment.
+ Participates in a weekly rotating 27/4 on-call CTU service (when alerted for a temperature excursion) with the other Lab Supervisors. Responsibilities include inhibiting alarms in the CTU monitoring software and coming on-site to relocate contents from the failing CTU to a back-up CTU within the allowable timeframe (2 hours or 5 hours) for the type of CTU.
+ Mentors/coaches other Lab Supervisors, provides training and seeks opportunities to develop skills.
+ Other duties as assigned by management.
Requirements
Education:
+ Bachelor's Degree - Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work-experience.
Experience:
+ 3-4 years Relevant industry experience working in an IVD GLP/ISO regulated laboratory environment. (required)
+ 5+ years Relevant industry experience. Experience in audits, knowledgeable in requirements and controls for IVD product development lab, (e.g. ISO 13485, GLP, GDP) or similar regulated lab environment. (preferred)
Knowledge, Skill or Ability Requirements:
+ Possesses excellent people skills with ability to collaborate and build effective internal/cross-functional relationships.
+ Strong desire to work in a highly regulated environment, with diligent attention to detail to ensure Development laboratory areas meet regulatory, departmental, and safety requirements.
+ Willingness to take on new challenges, perform additional tasks when necessary, and work at other RSS sites if necessary to meet Research & Development needs and support business goals.
+ Experience as an effective technical writer with a proven ability to quickly learn and understand complex subject matter with a keen eye for detail. Experience in writing and/or revising documentation and procedures for various audiences. Excellent written and verbal communication skills.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Source : System One
