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Senior Lab Supervisor
2881 Scott Blvd. Santa Clara, CA 95050 US
Job Description
Target Pay Rate: 39-50/hr **salary will be commensurate with experience
Job Description:
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 nonclient 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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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