POSITION PURPOSEThe 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.
ESSENTIAL FUNCTIONS AND BASIC DUTIES- 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
PERFORMANCE MEASUREMENTS- On time closure of QC Laboratory Investigations
- On time preparation and Delivery of weekly status reports
- On time preparation and Delivery of Monthly Quality Review Committee meeting slide
EDUCATION/CERTIFICATION- Bachelor's degree in chemistry / biological sciences. Master's level preferred
REQUIRED KNOWLEDGE- 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
REQUIRED EXPERIENCE- 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
SKILLS/ABILITIES- 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.
- Additional certifications such as CQE, CQA, ASQ-Six sigma green belt or black belt desirable
WORKING CONDITIONS- No hazardous or significantly unpleasant conditions
Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored visa sponsorship. SALARY RANGE- $90,000 - $100,000 annually, plus bonus
BENEFITSPDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:- 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
PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.
At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.
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