QC Investigator

QC Investigator

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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.

Essential Skills

• 5+ years of industry experience in pharma/med device preferred.
• Strong analytical chemistry
• Experience in investigation and root cause analysis.
• Proficiency in technical writing, USP, FDA, GMP, LIMS, and root cause failure analysis.
• Bachelor’s degree in chemistry or biological sciences; Master’s level preferred.
• 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.
• 3+ years in an analytical chemistry laboratory environment as a bench chemist with strong technical skills in the pharmaceutical/medical device/or 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.
• Superior communication and leadership skills.

Additional Skills & Qualifications

• 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.

Work Environment

The QC Investigator will be based 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). The role involves providing leadership and technical expertise to establish robust investigations during laboratory events. The QC Investigator will utilize knowledge of chemistry, cGMP, and analytical techniques to guide the investigation process and facilitate the completion of Phase I and Phase II reports. The role requires working with cross-functional teams to develop proper corrective and preventive actions for confirmed OOS events, supporting regulatory and customer audits, and interacting with customers regarding laboratory investigations.

This is a Contract position based out of Orangeburg, NY.

The pay range for this position is $45.00 - $50.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 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)

This is a fully onsite position in Orangeburg,NY.

This position is anticipated to close on Sep 2, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.