Quality Control Technologist III

Werfen; Warren Township (NJ); On-site; USD 95,000 - 125,000; Full time

Job summary

Werfen in New Jersey seeks a Quality Control lead to manage routine lab QC activities, schedule testing, and report daily status. You will train new staff, investigate OOS, and drive root cause analyses while upholding cGMP and regulatory requirements.

The role requires a biology/chemistry background, 5+ years in medical device/pharma QC, and experience with SOPs, WIN systems, and audits. No travel is required for this senior position.

Qualifications

• Bachelor's degree in biology or chemistry and 5+ years in a medical device/pharma QC lab.
• Experience with 21 CFR 210/211 and/or 820; ISO 13485 knowledge preferred.
• Proven ability to investigate OOS and conduct root cause analyses.

Responsibilities

• Provide direction to QC staff and schedule daily/weekly QC activities.
• Perform/testing planning for materials, in-process, and final release per SOPs.
• Train new employees and oversee OOS investigations and root cause analyses.
• Write/revise SOPs and QC documents; ensure cGMP compliance and records.
• Lead audits and participate in internal/external regulatory reviews.

Skills

Pipetting accuracy

Leadership

Problem solving

GMP knowledge

Software literacy

Education

Bachelor's degree in biology or chemistry

Tools

Laboratory software

SOP/WIN documentation

Job description

About the Position

This job is a lead role in the quality control laboratory, performing routine activities and assisting the manager in daily operations. This person knows how to execute all test methods performed in the lab. They schedule all testing activities in the lab and report status in daily update meetings. They train new employees, perform OOS and root cause investigations, perform data/record review, lead projects, and update WIN/SOPs.

Responsibilities

• Provides direction and guidance to Quality Control staff in the performance of daily tasks. Creates daily and weekly scheduling of all QC related activities
• Performs and schedules testing for incoming raw material, in-process, final release and inspection of BioArray products according to approved Standard Operating Procedures (SOP's) and other applicable documents within defined timeframes. Performs and schedules stability, method validations, equipment validations, threshold analysis process and other special testing.
• Act as OJT trainer to train new employees and current employees on new test methods. Guides QC technicians training activities and ensures that the appropriate training records are completed as per the role functions
• Reports and escalates out-of-specification results and deviations to the department supervisor/manager. Assists and leads the investigations, root cause analyses, and reports for out-of-specification results and deviations.
• Writes/Revises SOPs, WI, QC Specification/testing documents. Maintains accurate, legible, and complete records according to Current Good Manufacturing Procedures (cGMP's).
• Performs all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards).
• Maintains work area, equipment, department, and all storage areas in a clean, neat, and orderly manner. Performs, schedules and delegates equipment calibration and maintenance.
• Performs data review of QC test data. Works with quality assurance (QA) to ensure batch records are approved in a timely manner.
• Stay up-to-date on medical device regulations. Participate in internal and external audits.
• Performs other duties and responsibilities as assigned

Networking and Key Relationships

• Quality Assurance and Quality Control
• Operations
• Regulatory Affairs
• Technical Support and R&D

External Partners

• External auditors
• Regulatory agencies

Qualifications

• Bachelor's degree in biology or chemistry or related field. Five (5) or more years experience in a medical device or pharmaceutical GMP quality control laboratory. Experience working under 21 CFR Part 210/211 and/or 820 regulations required. Knowledge of ISO 13485 desired.
• Two (2) or more years of experience performing out of specification (OOS) and/or root cause investigations (RCI) required. Experience with test method validation, performing data trending, and writing/revising SOP/WIN preferred.
• Experience performing OOS Phase I investigations, in alignment with FDA guidelines, required.
• Experience training QC technicians desired.
• Experience performing PCR (Polymerase chain reaction) desired.
• Experience in internal/external audits is a plus.

Skills & Capabilities

• Ability to accurately pipette solutions from 0.01 ul up to 10 ml.
• Critical thinking and problem solving abilities
• Ability to learn and work with software programs (off-the shelf and company designed)
• Ability to work in a GMP lab environment, including donning the appropriate PPE (personnel protective equipment)
• Overtime work may be required (occasionally)
• Ability to lead others to complete tasks and projects

Travel Requirements

No travel is required for this position.

Equal Opportunity Employer Statement

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [e-mail] for assistance.