QC Laboratory Validation Specialist

Avantor is looking for a Quality Control Laboratory Validation Specialist to optimize our Quality Control Laboratory group. The Specialist will be responsible for investigating out-of-specification (OOS) results, implementing corrective and preventive actions (CAPAs), and qualifying equipment. A key priority will be transitioning a large volume of instrumentation from the current network to a new, improved system.

This position will be based at our chemical manufacturing facility in Phillipsburg, NJ.

What we're looking for

• Education: Bachelor's degree is required; Degree concentration in Chemistry or Biochemistry is preferred
• Experience: Minimum 2 years of Quality Control (QC) lab experience, including lab techniques is required
  • Qualifying and validating laboratory equipment, instruments, and systems
  • Developing validation plans, protocols, and testing specifications
  • Analyzing validation reports
• Collaboration Tool: Microsoft Office
• Preferred Qualifications:
  • GMP or pharmaceutical laboratory experience
  • Out of specification investigations (OOS) highly preferred
  • Lean six sigma and continuous improvement highly preferred
  • LIMS
  • SAP

How you will thrive and create an impact

As a Specialist, you will lead investigations into Out-of-Specification (OOS) results, identify root causes, and implement effective Corrective Action and Preventive Actions (CAPAs). You'll also conduct internal audits and collaborate with cross-functional teams. Including, you'll support equipment, instrument, and system validation by developing plans, protocols, and testing specifications-analyzing results to recommend improvements and ensure compliance during regulatory inspections.

• Provide on the floor and technical support to the Quality Control team
• Manage CAPAs, including investigation and implementation
• Support and enforce the quality system, regulatory policies and work instructions
• Arrange for equipment, materials and supplies to be available for work projects
• Monitor maintenance and calibration of equipment
• Troubleshoot laboratory instrumentation/ equipment to determine cause and arrange for repair/maintenance
• Review and approve controlled quality control documents
• Ensure department documents and procedures are up to date and reflect current SOPs
• Perform laboratory investigations for out of specification (OOS) results, safety related incidents and/or processes
• Partner with customers, regulatory agents and vendors during audits and site visits
• Enforce prescribed safety rules and regulations
• Embody a culture of inclusiveness
• Performs other duties as assigned

#LI-Onsite

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

Pay Transparency:

The expected pre-tax pay for this position is

Actual pay may differ depending on relevant factors such as prior experience and geographic location.

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.comand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

Avantor offers a comprehensive benefits package including medical, dental, and vision coverage, wellness programs, health savings and flexible spending accounts, a 401(k) plan with company match, and an employee stock purchase program. Employees also receive 11 paid holidays, accrue 18 PTO days annually, are eligible for volunteer time off and 6 weeks of 100% paid parental leave (except in states that offer paid family leave). These benefits may not apply to employees covered by a collective bargaining agreement or those subject to other eligibility rules.