QC Specialist

RXinsider LTD.; Indianapolis (IN); On-site; USD 28,000 - 39,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA PSS Insourcing Solutions is seeking a QC Specialist to perform routine testing and ensure data quality in a GMP environment. The role includes SPV of analytical data, investigations, equipment calibration, and contributing to continuous improvement.

The successful candidate will work in a regulated lab, follow SOPs, and support lab safety and data integrity while training colleagues and maintaining equipment qualifications.

Qualifications

• Proficiency with computer systems, including MS Office and LIMS.
• Ability to work in a regulated laboratory environment.
• Strong math and documentation skills.
• Ability to repetitively lift up to 20 pounds.
• Demonstrated strong oral and written communication and interpersonal interaction skills.

Responsibilities

• Perform analytical testing of routine lab samples per GMP guidelines.
• Participate in SPV of analytical data and investigations.
• Review results for accuracy and conformance to standards.
• Troubleshoot equipment and methods as needed.
• Train others and maintain safe lab practices.
• Maintain calibration and routine equipment qualifications.

Skills

Lab environment experience

Documentation skills

Oral and written communication

Safety awareness

Tools

MS Office

LIMS

Smart Lab

Darwin

SAP

SAP/EWM

Job description

At Eurofins PSS, we work with leading international companies across the pharma, medical device, food, cosmetic & consumer products industries - who all trust us with their mission-critical testing. For 20 years, our international network of teams have served clients at their sites, across 20 countries.

PSS® is part of Eurofins Scientific, an international life sciences company, providing a unique range of analytical testing services across multiple industries, through a network of over 950 laboratories in 60 countries, and c.a. 63,000 employees.

Life at Eurofins is a meritocracy, where people are empowered to make decisions and are rewarded for their success, allowing them to advance quickly. Become your most extraordinary self with support and development throughout your career.

Job Description

The QC Specialist performs accurate and timely testing of routine lab samples in accordance with appropriate GMP and safety guidelines. The QC Specialist will also participate in second person verification (SPV) of analytical data, laboratory investigations, equipment calibrations, and maintenance by executing well-defined protocols and procedures. The QC Specialist identifies and communicates opportunities for improvement within the lab.

• Accurately and safely performs analytical test methods or related support activities as per procedures or protocols and reviews that results conform to standards.
• Performs data entry and reviews own work for accuracy in accordance with laboratory procedures, standards, and GMP requirements.
• Recognizes when a deviation from procedures, etc. has occurred and initiates an investigation, notifies supervision.
• Verifies (SPV ) analytical data of other analysts within the lab as required.
• Identifies and communicates opportunities for improvement initiatives in daily work activities.
• Troubleshoots equipment and methods as required.
• Trains others within lab.
• Performs routine equipment qualifications / calibrations or maintenance through execution of well-defined protocols.
• Participates in laboratory investigations.
• Maintains a safe work environment, works safely, and is accountable for supporting all HSE Corporate and Site goals.
• Effectively utilize time management skills to prioritize work, ensuring all requested due dates and commitments are met.
• Identify and implement continuous improvement efforts related to the execution of above job responsibilities.

Qualifications

• Proficiency with computer systems, including Microsoft Office products, LIMS (list other lab systems, Smart Lab, Darwin, SAP), etc.
• Ability to work in a lab environment, including wearing appropriate PPE and other safety equipment and considerations.
• Ability to work in a highly regulated environment.
• Demonstrated strong math and documentation skills.
• Ability to repetitively lift to 20 pounds.
• Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.
• Demonstrated strong oral and written communication and interpersonal interaction skills.

Additional Preferences

• Prior experience with SAP/EWM

Other Information

• Position has the potential to change or extend scope after a year, based on client needs.
• Ability to work 8-hour days – Monday through Friday. Ability to work during summer/winter shutdown as needed.
• Ability to work overtime as required.
• Tasks require repetitive motion and standing for long periods of time.
• May be required to respond to off-shift operational issues.

Additional Information

• Position is full-time, 8:00 am- 5:00 pm Overtime as needed.
• Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.