Quality Control Specialist Ii/iii (metrology Technical Writer)

The growing Metrology team is searching for a technical writer to fill the position of Quality Control Specialist II/III to help develop a library of documentation and perform equipment qualifications for laboratory instrumentation. Successful candidates will showcase experience authoring technical documents associated with onboarding and maintaining GMP equipment specific to the pharmaceutical industry. Primary responsibilities include the initiation, execution, and review of laboratory qualification (IQ/OQ/PQ) and processing associated data for qualification. Capabilities of the QC Specialist II/III will be to identifies critical quality objectives, develop cross-functional, collaborative, and creative teams, and improve, adapt, and execute practical solutions in competitive and fast-paced environments.

Duties and Responsibilities

• Independently authors and revises technical qualification protocols, SOPs, and documents associated with onboarding new technologies into the GMP workspace
• Collaborates with different departments and cross-functional teams to gather information associated with new technical concepts
• Provides technical expertise (SME) on various equipment (HPLC/GC/Dissolution/XRD/TOC)
• Performs qualification of laboratory instruments and equipment
• Collaborates with laboratory personnel, Vendor Technicians, and Instrument Services to define qualification requirements
• Authors, reviews and executes qualification protocols and generates equipment lifecycle documents
• Coordinates equipment purchase and qualification activities with vendors, and site support groups (e.g. procurement, Instrument Services, Production Maintenance, and laboratory personnel)
• Decommissions aging instruments and equipment
• Identifies business, quality, and compliance gaps and proposes improvements to systems and procedures
• Reviews and approves peer qualification documents
• Oversees a broad range of documentation including, but not limited to User Requirement Specifications (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Change Controls, and Risk Assessments
• Works with cross-functional teams to troubleshoot equipment, testing, and validation issues
• Generates KPI’s
• Performs all other related duties as assigned

Required Skills and Abilities

• Ability to work and communicate collaboratively with internal and external independent contributors and stakeholders
• Ability to train employees in new procedures
• Excellent verbal and written communication skills with proven ability to communicate clearly and precisely
• Ability to function well in a high-paced and at times stressful environment
• Demonstrates high degree of self-motivation with limited supervision
• Excellent organizational skills with strict attention to detail
• Proven ability to problem-solve, think critically, and troubleshoot while working independently
• Proficient with Microsoft Office Suite or related software

Education and Experience

• Bachelor’s degree in related scientific discipline; advanced degree preferred
• Minimum of 5 years of GMP and Quality experience in the Pharmaceutical or Biotechnology fields
• Minimum of 3 years of experience with equipment validation/qualification activities
• Experience with regulatory inspections by the FDA and EU authorities preferred
• Extensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development, including through product commercialization preferred

Physical Requirements

• Prolonged periods of sitting or standing at a desk and working on a computer
• Must be able to lift up to 25 pounds at times