QC Systems Lead

Your Role:

This position is responsible for and accountable for the project management and implementation of the

Nugenesis laboratory data management system for Exelead. This position is also responsible for the

QC electronic systems and data integrity of the QC Chemistry laboratory. This position also supports

the technical review of analytical and microbiological test data from method validations, method

qualifications, and release testing.

Major Position Activities & Responsibilities:

• Act as Millipore Sigma project lead and provide technical expertise for implementation of the Nugenesis validated laboratory management system in the QC lab Act as QC electronic systems lead for Empower software (includes custom fields) and Validated Spreadsheets
• Ensure QC laboratory meets compliance requirements for data integrity. This includes instruments and their associated software. Assist with or lead data integrity projects when needed.
• Serve as a backup Qualified Scientist when needed by performing an in-depth technical review of all analytical and microbiological testing performed on finished products, in-process samples, stability samples, raw material samples, and environmental samples; ensuring compliance with cGMPs, approved methods and associated SOPs, and method validation requirements
• Assist laboratory management as a mentor in the development of all levels of analysts in the laboratory. This mentorship includes technical guidance regarding GMP fundamentals chromatographic/spectrographic systems, and general analytical testing
• Provide laboratory information and documentation requests to site management and CM customers required for regulatory filings and product import/export needs, when required
• Review product trends and identify out-of-trend results and perform laboratory investigations, as needed
• Review and provide input on method validation and method qualifications, and method and SOP compliance improvements
• Participate in and adequately represent the laboratories in customer and regulatory audits of the facility, as needed
• Participate in and lead projects for continuous improvements in QC systems, methods or method execution
• As a part of the employee’s job requirements, the employee may be required to handle waste including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training

Who You Are

Required Qualifications:

• Position requires a bachelor’s degree in chemistry or related field
• 7+ years more of pharmaceutical industry experience and 6 or more years in Quality Control experience required
• Extensive experience in chromatography methods (e.g., HPLC, UPLC, GC) and technologies

required. In addition, experience with UV/VIS Spectrophotometry, FTIR Spectrophotometry, and other analytical techniques

•  Extensive experience in chromatography integration software (e.g., Empower, ChemStation,

Chromeleon, Totalchrom)

Preferred Qualifications:

Master’s degree preferred

• Proven skills coaching/mentoring technical laboratory staff in a GMP/GLP laboratory environment
• Method transfer and method validation experience desired
• The position requires proven ability and skill in analyzing, understanding and presenting technical data
• Experience in technical writing, communicating across organizational levels, and data analysis and trending is expected
• Good interpersonal skills are a must