Jobs

Description

100% on-site Local preferred

Ideally the candidates have lab instrument qualification experience.

Education: BA in Chemistry, Biology, Engineering

Must-Have Experience with:  Qualifying analytical instruments/equipment, HPLC

 Work Experience: 2 year industry minimum

Description:

USA-Quality Control Technician II (Manufacturing/Quality) 1st Shift: QC Instrument Support (QCIS)

• This position will support the lifecycle management of instrumentation within the Quality Control department at the Swiftwater, PA location while strictly adhering to Client procedures, Health Authority Regulations, and cGMP's.

Main Responsibilities:

• Provide instrumentation support that impacts the Quality Control Laboratory including qualification, calibration, and preventive maintenance
• Assist in completion of change controls, deviations, CAPA's to support timelines
• Author cGMP documentation including protocols, reports, procedures, and user requirement specifications
• Assist in implementing new technologies to improve QC testing efficiency and capabilities
• Support QC laboratory inspection readiness
• Develop an understanding of best practices for optimal equipment operation and compliance to regulatory requirements
• Follow cGMPs and strictly adhere to Client policies and procedures
• Complete required training as assigned

Technical Competencies:

• Working knowledge of cGMP's, Regulatory requirements, and data integrity concepts
• Ability to work cross-functionally with other departments and involved stakeholders
• Lead projects related to analytical instrumentation
• Aptitude working within computerized systems
• Understanding of analytical instrumentation concepts and technologies
• Strength in Client Play to Win Behaviors – Stretch, Take Action, Act for Patients and Customers, Think Client First

Basic Qualifications:

• Bachelor's or Master's degree in Life Sciences or Engineering is required
• 2+ years’ experience in a cGMP laboratory setting
• Vaccinations as required

Preferred Qualifications:

• Demonstrated customer focus and experience in support roles
• Prior experience maintaining laboratory instrumentation
• 3+ years’ experience in cGMP laboratory setting

Location Information:

• This position will be based out of the Swiftwater, PA facility
• On site attendance is required