Here's What You'll Do- Provide leadership for assigned duties at ElevateBio's facility including overall supervision of associates and contractors performing calibrations, and various testing activities.
- Provide direction of group activities as necessary, resolution of problems/issues with contractors, vendors, and internal and external clients.
- Track and maintain progress towards completion of scheduled workloads, reassign resources to meet timelines.
- Review and approve departmental procedures, work orders, and reports. Drive systems improvements.
- Train and mentor staff on equipment, procedures, and systems.
- Work with System/Equipment owner to set Calibration Tolerances and ranges.
- Generate and revise SOP's for Metrology program and equipment specific calibrations.
- Maintain a safe work environment for all employees, customers, and processes.
- Achieve a high level of service that will control costs, support cycle time, and maintain the quality, operation, integrity, and traceability of measurement equipment while meeting regulatory requirements.
- Identify, report, and effectively resolve quality issues. Prepare for and support internal and external quality audits of metrology operations and equipment. Be a subject matter expert with ability to effectively communicate with internal and external auditors and investigator.
- Stay current on industry best practices to continuously improve laboratory operations. Develop knowledge retention and training program to ensure employees have the appropriate skills and capabilities to perform at a high level.
Requirements- Bachelor's degree and at least 8 years of related experience or Master's degree with at least 6 years of related experience; or a PhD with at least 4 years of experience.
- Experience with Calibrating process, laboratory, packaging, and utility systems instrumentation/equipment in a GMP environment
- Ability to multitask and always maintain professionalism
- Strong Microsoft Excel skills
- Proficient in Microsoft Office products (Outlook, Word, Excel, etc.)
- Experience working with Blue Mountain RAM or other CMMS programs preferred
- Ability to read, understand, and follow SOP, P&ID's and work instructions
- Strong communication skills in both oral and written reports
- Reviewing GMP documentation for accuracy and compliance
- Participating in client, regulatory, and internal audits
- Have a working knowledge of industry guidelines
- Experience presenting and defending Calibration Program in Regulatory Audits.
Preferred QualificationsPhysical and Environment Requirements (if applicable):- Ability to stand, walk, bend and stretch for extended period of time
- Ability to lift 25-50 lbs
- Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
- Ability to perform routine repetitive motions with use of arms, wrists and hands
The budgeted range for this position is $150,000 - $200,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.
