Associate Specialist, Quality Control, Lab Support

Technical Support Associate Specialist, QC

We are seeking a growth and improvement minded Technical Support Associate Specialist in Quality Control that can help drive our strategic operating priorities.

The Technical Support Associate Specialist, QC is responsible for advanced preparation of maintenance jobs; responsible for maintaining equipment data, preventive maintenance data and calibration data; processes change control for equipment and preventive maintenance documentation, coordinates calibration program, coordinates maintenance planning operations within the laboratory for consistency, plans and schedules maintenance work orders, schedules PM's, maintains equipment histories, analyzes equipment & preventive maintenance effectiveness, and tracks maintenance metrics.

They demonstrate mastery of all maintenance management programs (Inventory Control, Calibration Program, Preventive Maintenance Program, SAP, Work Order Control, etc.). Maintain positive vendor relations and support review/completion of vendor services. Assures compliance with FDA & GMP regulations. Demonstrates the ability to influence a team (including Global Support and Outside Vendors) in the effort to solve and execute corrective maintenance work and complete preventative maintenance work.

Is a recognized resource to others when developing new maintenance reports, standards, and metrics. Provides input in the management of Maintenance and Repair Budgets. Implements cost saving initiatives. Uses vast experience in maintenance to conduct in-depth review of maintenance planning responsibilities to suggest and implement process improvement ideas.

Key Functions

• Work independently and as a team member with integrity | precision | accomplishment | motivational ambition | respect | inclusion
• Participate in development of objectives and ensures alignment with site goals

• Initiating/leading problem solving to identify short-term and long-term actions to prevent problem reoccurrence, reduce laboratory downtime and increase equipment reliability
• Following standard work for escalation as it related to safety, quality and downtime events
• Timely approval of qualification, change control, procedures and other documents
• Providing operational subject matter expert support/direction for the installation of new equipment and/or modifications to existing processes and/or equipment
• Demonstrates a deep understanding of customer needs, requirements, and expectations.
• Pays close attention equipment use/maintenance and proactively steps in to help as needed.
• Maintains equipment preventative maintenance/calibration programs

• Attends departmental and team meetings focused on equipment/process improvement
• Serves as liaison between NASU teams, leadership, and external vendors
• Ability to interpret our company quality policies and guidelines for daily application.
• Participates and/or directs tier meetings
• Promotes teamwork and open discussion of issues.

• Uses root cause analysis tools to identify true root cause for quality and safety events
• Authors, reviews, approves and/or participates in quality investigations
• Participates in internal and external audits and inspections
• Identifies equipment-related trends and facilitates implementation of corrective actions
• Creates/revises standard operating procedures, forms and other equipment-related documents
• Understands and applies regulatory/compliance requirements, including GMP, NDA, and related regulations, and can interpret those regulations for implementation in the workplace.

Minimum Education Requirements

• Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering

Required Experience and Skills

• Prior experience in a pharmaceutical laboratory setting
• Knowledge and experience of CMMS systems is essential, ideally SAP
• Experience managing vendors and contractors
• Working knowledge of cycle time and inventory management, GMP's, government regulations

Required Skills:

Adaptability, Analytical Problem Solving, Aseptic Manufacturing, Auditing, Contractor Management, Corrective Action Management, Corrective Maintenance, Data Analysis, Environmental Monitoring, Equipment Reliability Improvement, GMP Compliance, Inventory Management, Inventory Planning, Laboratory Instrumentation, Laboratory Operations, Laboratory Testing, Maintenance Planning, Maintenance Planning Software, Oncology, Preventive Maintenance, Process Improvement Projects, Quality Control Inspection, Raw Material Testing, Regulatory Compliance

The salary range for this role is $65,100.00 - $. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a…