Calibre Jobs in Usa

ANEUVO is developing breakthrough neuromodulation devices and bioelectronic medicine to treat diseases and injuries that are incurable with conventional pharmacological agents. We are building a cohesive team with complementary and multidisciplinary expertise to develop and bring our products to market.

We are currently looking for a detail-oriented and reliable Production Operator / Technician to join our manufacturing team in producing high-quality medical devices. You will be responsible for operating equipment, assembling components, inspecting products, and ensuring adherence to strict regulatory standards such as ISO 13485 and FDA cGMP.

Key Responsibilities:

• Operate and monitor production equipment according to SOPs (Standard Operating Procedures)
• Assemble medical device components manually or using automated tools
• Perform in-process inspections and testing to ensure product quality
• Maintain accurate records of production output, defects, and downtime
• Follow Good Manufacturing Practices (GMP), cleanroom protocols, and safety guidelines
• Participate in root cause analysis and continuous improvement activities
• Support equipment maintenance, calibration, and troubleshooting
• Collaborate with quality, engineering, and warehouse teams to meet production goals

Qualification:

• High School diploma or GED required; Associate degree or technical certification preferred
• 3 to 5 years of experience in a manufacturing environment, preferably medical device or pharmaceutical
• Basic knowledge of GMP, ISO 13485, and cleanroom standards
• Ability to read technical drawings, work instructions, and production schedules
• Strong attention to detail and manual dexterity
• Ability to stand for long periods and lift up to 30 lbs
• Comfortable working in controlled environments

Preferred Qualification:

• Experience with medical device assembly
• Familiarity with electronic batch records (EBR) and ERP systems
• Ability to work effectively in a team-oriented, fast-paced environment
• Good written and verbal communication skills

What we offer:

• A unique opportunity to drive a revolution in medical practices and to significantly improve the health condition of patients
• A unique environment for you to exercise your talents and be impactful
• Medical, dental and vision insurance
• Employee stock options

Last but not least, we are a small team and thus everyone plays a critical role - your voice will be heard clearly and loudly! Come join us and build the future, today.

Quality Control Manager – Machine Parts

Location: West Chester, Pennsylvania

Industry: Precision Medical Device Manufacturing

Job Type: Full Time | 100% Onsite

Shifts: 1st (7:00am–3:30pm), 2nd (3:00pm–11:30pm)

Position Overview

Leads quality control activities for precision-machined medical device components. Responsible for inspection planning, First Article and in-process inspections, nonconformance management, ISO compliance, ERP tracking, and mentoring quality staff across machining cells and shifts.

Core Responsibilities

• Develop and oversee inspection plans across machining cells
• Perform and review First Article Inspections and in-process inspections
• Lead nonconformance investigations, MRBs, and corrective actions
• Maintain ISO 9001 and ISO 13485 compliance
• Track quality data and documentation within ERP systems
• Train and mentor inspectors and machinists on quality standards
• Support internal audits and calibration programs

Must-Have Qualifications

• 5+ years quality experience in precision machining environment
• Strong blueprint reading and GD&T knowledge
• Experience performing FAIs and in-process inspections
• Experience managing nonconformance and corrective actions
• Familiarity with ISO 9001 and ISO 13485 systems
• Ability to mentor and train quality personnel

Preferred Qualifications

• CNC or Swiss machining background
• Experience supporting audits and calibration programs
• ERP system experience in manufacturing setting
• Engineering degree or equivalent hands-on experience

Work Environment & Process

• Precision, climate-controlled medical device facility
• Regulated and quality-driven environment
• Uniforms and safety equipment provided at no cost
• Overtime based on production demands
• Interview process includes virtual interviews, onsite visit, and skills assessment

Kelly® Science & Clinical is seeking a Quality Assurance Validation Specialist for a contract position at a premier pharmaceutical client in Irvine, CA If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Empowering Experts.

Job Title: QA Validation Specialist (Contract)

Duration: 10 months

Location: Irvine, CA (onsite)

Rate: $38–40/hr.

This position involves hands-on ownership of equipment, facility, and laboratory validations. Ideal for experienced validation professionals who excel in regulated environments and enjoy driving projects from protocol development through audit-ready execution.

RESPONSIBILITIES:

• Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.
• Authors/approves and executes qualification protocols and reports.
• Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory Instruments in coordination with operations, Quality Control and maintenance.
• Assists sourcing and procurement of facility equipment and Laboratory Instruments through completion of following tasks
• Qualification of Vendors Selected.
• Input to the development of the URS/FRS/DDS.
• Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
• May present qualification studies to Regulatory and Client Auditors as required.
• Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
• Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.
• Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
• Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
• Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
• Initiates and investigates exception reports and non-conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.
• Other responsibilities and special projects will be assigned based on business and customer needs.

QUALIFICATIONS:

• Bachelor’s degree in Sciences
• 5+ year’s of experience in a highly regulated pharmaceuticals industry or related field
• Strong working knowledge of cGMP and regulatory standards for validation.
• Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.
• Demonstrated experience with qualification of commercial processing a packaging equipment.
• Proven track record of managing projects from start to finish on time and on budget.

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

This is a six month assignment in Vacaville

This potsition is for local candidates as there is no travel and living expenses

This is a W2 Position.

Process Engineer I

Summary:

This position is located at Lonza’s production facility in Vacaville, California. The production facility makes pharmaceutical proteins from mammalian cells using large-scale production techniques. This temporary contract position provides hands-on technical support for Process Analytical Technology (PAT) systems deployed on the manufacturing floor at a large-scale biopharmaceutical facility. PAT systems play a critical role in monitoring mammalian cell culture processes by measuring key parameters such as cell density, viability, and metabolite concentrations. Maintaining these systems in a reliable, ready-to-use state is essential for ensuring consistent manufacturing performance.

In this role, you will support day-to-day operation, maintenance, and troubleshooting and repair of PAT instruments used in GMP manufacturing. You will work closely with the Frontline Upstream (FLUS) System Owner, Manufacturing, and Instrumentation staff to assess system issues, perform equipment health checks, execute planned improvements, and assist with investigations into unplanned events. This position supports the increased workload associated with the deployment of several new PAT systems in parallel with existing instruments. This position offers the opportunity to gain hands-on experience with advanced PAT used to support mammalian cell culture and purification operations. The FLUS and Instrumentation groups provide technical support for a wide range of analytical instruments used to monitor cell growth, metabolite profiles, and process performance throughout the manufacturing lifecycle.

Job Duties:

Responsibilities/activities may include, but not limited to:

• Performing routine maintenance, calibration checks, and system readiness activities for PAT instruments such as cell counters and metabolic analyzers (e.g., Cedex Bio, Cedex HiRes, Cedex Cobas).

• Supporting manufacturing operations by responding to system-related issues, troubleshooting instrument performance, and documenting observed problems.

• Assisting in the investigation of unplanned equipment events using structured problem-solving tools and contributing to root cause assessments.

• Conducting equipment health monitoring and contributing to reliability improvement activities to increase system uptime.

• Executing planned equipment changes, minor upgrades, and configuration updates under the direction of the PAT System Owner.

• Reviewing and interpreting instrument data to identify basic trends or abnormalities.

• Supporting adherence to data integrity principles and helping maintain data consistency within systems such as Smartline Data Cockpit.

• Collaborating with Manufacturing, FLUS, Automation, QA, and vendors to ensure systems are functioning as intended.

• Assisting with documentation updates, tracking of work activities, and preparing technical summaries as needed.

• Working independently to accomplish assigned tasks while keeping stakeholders informed of progress.

Education and Experience:

• B.S., M.S., or Ph.D in an engineering or analytical/scientific discipline.

• Prior hands-on experience with analytical systems is required.

• Experience using cell counters and metabolite analyzers (Cedex Bio, Cedex HiRes, Cedex Cobas) in GMP Manufacturing or QC Labs preferred.

Knowledge/Skills/Competencies:

• Working knowledge of current Good Manufacturing Practices (cGMPs) as applied to biopharmaceutical manufacturing or similar regulated industries.

• General understanding of biotech analytical methods and laboratory practices.

• Experience troubleshooting analytical instruments and interpreting equipment performance data.

• Flexibility in problem solving and work hours to meet business objectives.

• Familiarity with data management systems; experience with Smartline Data Cockpit is highly desirable.

• Strong interpersonal and communication skills; able to work effectively with operators, engineers, scientists, and external vendors.

• Ability to work independently and manage assigned tasks with limited supervision.

• Demonstrated ability to evaluate technical situations, propose solutions, and execute corrective actions.

• Strong verbal and written communication skills, including documentation, reporting, and stakeholder updates.

• Ability to build productive working relationships with end users and equipment vendors.

• Strategic thinking mindset with the ability to convert system needs into actionable activities.

• Builds productive relationships with partners; focuses on customer needs.

KCU - Joplin is hiring an Assistant Director of Curriculum for the College of Dental Medicine. This is an exciting opportunity for a dentist looking to step into academia.

This dental faculty member will provide leadership and oversight for the design, delivery, assessment, and continuous improvement of the Doctor of Dental Medicine (DMD) curriculum. As a licensed dentist and academic leader, the Assistant Director works in close collaboration with the Assistant Dean of Curriculum and Integrated Learning to ensure that the predoctoral program provides students with a rigorous, integrated, and competency-based educational experience.

The Assistant Director plays a pivotal role in preparing students for successful entry into patient care, fostering a culture of educational innovation, and ensuring that the DMD program maintains the highest standards of academic excellence and clinical relevance.

Essential Duties and Responsibilities:

Curriculum Leadership and Oversight

• Collaborate with the Assistant Dean to ensure the DMD curriculum is innovative, evidence-based, and aligned with institutional and CODA standards.
• Review, update, and approve course syllabi for accuracy, clarity, and integration across the curriculum.
• Guide the implementation of integrated learning strategies across biomedical, behavioral, and clinical science courses.
• Identify opportunities for curricular innovation and integration, and collaborate with the CDM team to implement them.

Assessment and Competency Development

• Oversee rubric development, review, and calibration processes for formative and summative assessments in both pre-clinical and clinical settings.
• Coordinate faculty calibration in grading and competency evaluation to promote fairness and consistency alongside the Assistant Director of Faculty Development.
• Monitor student progression toward achievement of program competencies, including analysis of reports, dashboards, and data-driven recommendations.
• Lead initiatives to assess the effectiveness of educational outcomes and implement continuous quality improvements.

Faculty and Administrative Support

• Serve as a resource and mentor to faculty in curriculum design, assessment, and educational best practices.
• Provide faculty development opportunities in competency-based education and assessment methodology.
• Assist the Assistant Dean in managing the operational responsibilities of the curriculum office, including scheduling, accreditation preparation, and policy development.
• Contribute to institutional reporting, strategic planning, and accreditation site visit preparation.
• Assume responsibility for didactic and clinical coverage as necessary to support programmatic and patient care needs.

Collaboration and Service

• Serve as a liaison between faculty, course directors, students, and academic leadership to facilitate curricular charge.
• Participate in relevant committees related to curriculum, assessment, student success, and accreditation.
• Support institutional initiatives in educational innovation, interprofessional education, and continuous quality improvement.

Qualifications:

Required:

• DMD/DDS degree from a CODA-accredited institution.
• Current licensure (or eligibility for licensure) in the United States.
• Preferred experience in academic dentistry with demonstrated involvement in teaching, curriculum design, and/or assessment.
• Knowledge of competency-based education, rubric development, and evaluation of clinical skills.
• Strong organizational, communication, and leadership skills.
• Commitment to student success, mentorship, and continuous program improvement.

Preferred:

• Advanced training in dental education, academic leadership, or health professions education (e.g., certificate, fellowship, or graduate degree).
• Experience with CODA accreditation standards, self-study preparation, and compliance processes.
• Demonstrated success in faculty development and educational innovation.
• Experience with educational technology, assessment platforms, or curriculum management systems.

Job Description:

Pay rate: $28/hr

Onsite at Waltham, MA but facility moving to Cambridge, MA 02142

M-F schedule - possibility of daily and Sat OT

8 hr shift but may work 7am-4 or 9-5 depending on work load. Need to be available from 7a-5p

Safety Shoes required (Steel Toe or Composite Toe)

Dress Code: polo/button-up with regular khakis or slacks

What were looking for:

• High School diploma or GED is required; BA/BS Degree in science preferred.
• Minimum 1-2 years experience in a laboratory setting highly desired. Undergraduate lab work will be considered
• Microsoft Office experience required with proficiency in Word and Excel.
• Covid-19 vaccination required.
• Must be flexible, forward- thinking, motivated, and can act independently.
• High level of customer service skills with a professional, can-do demeanor.
• Requires laboratory knowledge including using various instruments to prepare for and perform tests.
• Able to lift 25 lbs.
• Effective communication, both verbal and written, with customer and internal stakeholders required.
• Ability to follow site protocols, policies, and procedures to stay safe, prioritize tasks, solve problems, ensure quality, and meet goals.
• Conform to all customer requirements for background checks, health and safety issues, and security clearances required.

In this role you will:

• The Lab Resource Coordinator is a key member of the laboratory operations team, providing essential support to scientific research groups. This role serves as a critical liaison between scientists and laboratory operations, ensuring smooth and efficient lab operations while maintaining a safe and productive work environment.
• Operational Support: Serve as the primary point of contact for scientific groups, addressing their day-to-day lab operational needs and inquiries.
• Lab Operations Compliance: Ensure adherence to all lab operations protocols and initiatives by science groups.
• Inventory Management:
• Maintain accurate records and inventory of common lab supplies and equipment.
• Coordinate with Avantor services teams (consumables, media/buffer, solvents, etc.) to meet lab needs.
• Catalog and maintain certain common stock items to minimize storage needs.
• Cold Storage Management: Organize and maintain cold storage space (deli fridges, -80C freezers, cryo units) for samples.
• Equipment Maintenance:
• Coordinate with Lab Instrument Services (LIST) for equipment tagging, calibration, and maintenance.
• Submit and track maintenance requests for lab equipment.
• Facility Maintenance:
• Assist with the upkeep of common lab areas (consumable racks, western blot equipment, cold room, TC rooms, equipment rooms).
• Submit work orders for lab issues and follow up on progress.
• Safety Compliance:
• Act as a safety committee representative, participating in safety walkthroughs and ensuring compliance with safety regulations.
• Assist with safety training for new hires.
• Training & Support:
• Provide training to new hires on general lab procedures and equipment.
• Assist with the lab coat program, including ordering, stocking, and communicating with vendors.
• Communication:
• Attend department meetings and effectively communicate information between science groups, lab operations, and other relevant teams.
• Space Optimization: Contribute to lab decluttering efforts and space utilization improvements.
• General Lab Assistance:
• Perform basic lab work as directed by science team leads, within the scope of work and contract agreements.
• Provide daily routine equipment assistance (e.g., checking solvent/buffer levels, calibration, instrument startup, waste handling).