Senior Lab Supervisor - Software Guidance & Assistance
Santa Clara, CA
About the Job
Software Guidance & Assistance, Inc., (SGA), is searching for a Senior Lab Supervisor for a contract assignment with one of our premier Pharmaceutical Services clients in Santa Clara, CA.
Responsibilities :
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy
Responsibilities :
- 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.
- 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-firm 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.
- Bachelor's Degree - Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work-experience.
- 3-4 years Relevant industry experience working in an IVD GLP/ISO regulated laboratory environment. (required)
- 5+ years Relevant industry experience.
- 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.
- 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)
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy
Source : Software Guidance & Assistance
