Description
ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.
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 Qualifications
- Nice to haves
Physical 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.
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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