Onsite Position
Job Summary:
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.
Job 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 user's 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 non-Roche branded 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.
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.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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Job Summary:
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.
Job 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 user's 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 non-Roche branded 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.
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.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.