QC Investigator

PDI•Orangeburg, NY

10d•Onsite

About The Position

Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE The QC Investigator provides the leadership and technical expertise necessary to establish robust investigations during laboratory events, out of specification, and out of trend events. This position utilizes knowledge of chemistry, cGMP, and analytical techniques to guide the investigation process and facilitated the completion of Phase I and Phase II reports. The QC Investigator will work with cross functional teams to develop proper corrective and preventive actions for confirmed OOS events. The incumbent will also support the trending associated with quality investigations, Key Performance Indicators (KPIs) and / or other Quality Metrics. This role will support regulatory and customer audits and interact with the customer to regarding laboratory investigations.

Requirements

Bachelor’s degree in chemistry / biological sciences.
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), 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 (over the counter) drug or cosmetic manufacturing facility.
Experience conducting of out of specification investigations is required.
Experience with in 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
Strong analytical skills.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to analyze data/information and to assess and resolve complex problems in a timely fashion.
Technical writing.
Ability to prioritize commitments and make decisions on best path forward to ensure timely investigation resolution.
Ability to work independently and stay on task in a fast-paced environment without direct supervision.
Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
Ability to wear personal protective equipment such as gloves, gowning, etc.

Nice To Haves

Master’s level preferred
Additional certifications such as CQE, CQA, ASQ-Six sigma green belt or black belt desirable

Responsibilities

Responsible for 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/or process failures within the quality control labs
Ensures integrity throughout the laboratory investigation process while adhering to applicable regulatory statute and standards.
Stays updated on best practices, quality trends and regulatory requirements
Facilitates the generation of clear, concise and thorough investigations by providing sound quality and technical feedback
Works alongside manufacturing, quality control, and other applicable departments to ensure that root cause analysis is complete, and investigation is completed in a compliant manner
Tracks, monitors, and facilitates timely closure of laboratory investigations
Ensures corrective action for OOS/OOT investigations is identified and implemented (as appropriate)
Identifies 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, as well as regulatory inspections
Handle special projects or assignments as directed by Quality Management team
Other duties as assigned

Benefits

Medical, behavioral & 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 & long-term disability
Employee Assistance Program (EAP)
Health Advocacy Program
Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.
sick & safe leave, vacation, company & floating holidays, paid parental leave
summer hours and flex place/flex time options