QC Investigator

Contract position based in Orangeburg, NY.

About the role

The QC Investigator is responsible for the oversight and execution of complex and critical Phase I and Phase II investigations related to quality control (QC) out-of-specification (OOS), out-of-trend (OOT), laboratory events (LE), and process failures within the quality control labs. This role ensures the integrity of the laboratory investigation process while adhering to applicable regulatory statutes and standards. The QC Investigator stays updated on best practices, quality trends, and regulatory requirements.

Responsibilities

• Facilitate the generation of clear, concise, and thorough investigations by providing sound quality and technical feedback.
• Collaborate with manufacturing, quality control, and other departments to ensure root cause analysis is complete and investigations are compliant.
• Track, monitor, and facilitate timely closure of laboratory investigations.
• Ensure corrective actions for OOS/OOT investigations are identified and implemented appropriately.
• Identify opportunities for continuous improvement.
• Interface with all levels of the organization on behalf of QC.
• Support the generation of monthly and other required Quality Metrics.
• Ensure spreadsheets/databases are current and available for investigation meetings and daily reporting.
• Participate in audits, including customer, internal, external, and regulatory inspections.
• Handle special projects or assignments as directed by the Quality Management team.

Requirements

• 5+ years of industry experience in pharma/med device preferred.
• Bachelor’s degree in chemistry or biological sciences; Master’s level preferred.
• 3+ years in an analytical chemistry laboratory environment as a bench chemist with strong technical skills in the pharmaceutical/medical device/biologics industry.
• A minimum of 5 years in a QC role in an NDA, OTC drug, or cosmetic manufacturing facility.
• Experience conducting out-of-specification investigations.
• Strong knowledge of good manufacturing practices (cGMPs) for FDA-regulated industries, ICH, and other applicable regulations.
• Knowledge of compendial testing methodologies (USP, Ph. Eu, etc.).
• Experience in QC analytical laboratory operations, equipment, software, processes, QC systems, and quality improvement tools.
• Proficiency in Microsoft Office Suite, LabWare LIMS, EDMS (Master Control), and advanced Excel skills.
• Superior communication and leadership skills.

Skills

• Strong analytical chemistry experience.
• Proficiency in technical writing, USP, FDA, GMP, LIMS, and root cause failure analysis.
• Knowledge of the FD&C Act, ICH, and 21 CFR Parts 210/211 & 11 along with industry standards for pharmaceutical and OTC drugs.
• Participation in continuous improvement activities in an analytical laboratory environment.

Schedule

On-site in Orangeburg, NY, working 5 days a week from 7:00 am to 3:30 pm (with flexibility to 8:00 am to 4:30 pm if needed).

Pay

The pay range for this position is $45.00 - $50.00/hr. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

If eligible, the benefits available for this temporary role may include:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)