QC Specialist

Eurofins PSS Insourcing Solutions; Indianapolis (IN); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins PSS Insourcing Solutions in Indianapolis, IN seeks a QC Specialist to perform accurate testing of routine lab samples in accordance with GMP and safety guidelines. The role includes SPV verification, data review, investigations, calibration, and improving lab processes.

Responsibilities include ensuring timely results, data integrity, and compliance with HSE goals. 8-hour weekdays, potential overtime, comprehensive benefits, and a strong team environment.

Qualifications

• Proficiency with computer systems including Microsoft Office and lab-specific software.
• Strong math and documentation skills.
• Ability to work in a highly regulated environment.
• Demonstrated attention to detail and accuracy in data handling.

Responsibilities

• Accurately and safely performs analytical test methods per procedures.
• Performs data entry and reviews own work for accuracy per GMP requirements.
• Initiates investigations when deviations occur and notifies supervision.
• Verifies SPV analytical data of others in the lab.
• Identifies opportunities for improvement in daily activities.
• Trains others within the lab and maintains equipment/calibrations.
• Participates in laboratory investigations and safety initiatives.

Skills

Computer skills

Math skills

Documentation

Regulatory awareness

Tools

SAP

LIMS

Smart Lab

Darwin

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.

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.

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.