Senior Quality Assurance Investigator

4 weeks ago


Orangeburg, New York, United States PDI Full time

At the forefront of quality assurance, PDI is dedicated to delivering cutting-edge solutions for the healthcare industry. With a strong commitment to innovation and customer satisfaction, we strive to establish a culture of excellence that permeates every aspect of our operations.

Job Summary

The Senior Quality Assurance Investigator - Laboratory Excellence Specialist will be responsible for leading complex quality investigations and providing technical expertise to ensure robust investigations during laboratory events, out-of-specification, and out-of-trend occurrences. This role will work closely with cross-functional teams to develop and implement corrective and preventive actions for confirmed out-of-specification events, while also supporting quality metrics and regulatory compliance.

Key Responsibilities
  • Oversee and execute comprehensive Phase I and Phase II investigations related to quality control (QC) out-of-specification (OOS), out-of-trend (OOT), laboratory events (LE), and/or process failures within the quality control labs.
  • Ensure the integrity of the laboratory investigation process while adhering to applicable regulatory statutes and standards.
  • Stay updated on best practices, quality trends, and regulatory requirements.
  • Facilitate the generation of clear, concise, and thorough investigations by providing sound quality and technical feedback.
  • Collaborate with manufacturing, quality control, and other applicable departments to ensure that root cause analysis is complete and the investigation is completed in a compliant manner.
  • Track, monitor, and facilitate timely closure of laboratory investigations.
  • Ensure corrective action for OOS/OOT investigations is identified and implemented as appropriate.
  • Identify opportunities for continuous improvement.
  • Interface with all levels of the organization on behalf of QC.
  • Support the generation of monthly and other quality metrics as required.
  • Ensure spreadsheets/databases are current and available for investigation meetings and daily reporting.
  • Participate in audits, customer, internal, external, and regulatory inspections.
  • Handle special projects or assignments as directed by the Quality Management team.
  • Other duties as assigned.
Requirements
  • Bachelor's degree in chemistry/biological sciences; Master's level preferred.
Essential Skills and Qualifications
  • Strong knowledge and understanding of good manufacturing practices (cGMPs) for FDA-regulated industries, ICH, and other regulations applicable to Good Laboratory Practices (GLP), Good Documentation Practices (GDP), Phase I analytical chemistry laboratory investigations, and Phase II manufacturing investigations.
  • Knowledge of compendial testing methodologies (USP, Ph. Eu, etc.).
  • Knowledge of QC analytical laboratory operations, equipment, software, processes, QC systems, quality improvement tools, and problem-solving techniques.
  • Laboratory investigation root cause analysis and corrective action.
  • Proficiency in Microsoft Office Suite, LabWare LIMS, EDMS (Master Control), and advanced Excel skills.
Experience
  • 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 (over-the-counter) drug, or cosmetic manufacturing facility.
  • Experience conducting out-of-specification investigations is required.
  • Experience with root cause analysis.
  • Knowledge of the FD&C Act, ICH, and 21 CFR Parts 210/211 & 11 along with industry-required standards for pharmaceutical and OTC drugs.
  • Superior communication and leadership skills.
  • Participation in continuous improvement activities in an analytical laboratory environment.
Salary Range

$85,000 - $100,000 annually.

Benefits

PDI offers comprehensive and affordable benefits for our associates, including:

  • Medical, behavioral, and prescription drug coverage.
  • Health Savings Account (HSA).
  • Dental.
  • Vision.
  • 401(k) savings plan with company match and profit sharing.
  • Basic and supplemental life and AD&D insurance.
  • Flexible Spending Accounts (FSAs).
  • Short and long-term disability.
  • Employee Assistance Program (EAP).
  • Health Advocacy Program.

PDI also offers many voluntary benefits, including:

  • Legal services.
  • Critical illness.
  • Hospital indemnity.
  • Accident coverage.
  • ID theft and fraud protection.
  • Pet insurance.
  • Employee discounts.

PDI is committed to helping our associates maintain a healthy and sustainable work-life balance and is proud to provide associates with paid time off programs, including:

  • Sick and safe leave.
  • Vacation.
  • Company and floating holidays.
  • _paid parental leave.
  • Depending on the position, we also offer summer hours and flex place/flex time options.


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