Senior Quality Control Specialist

Novo Nordisk•Boulder, CO

1d•Onsite

About The Position

The Senior QC Specialist will assist with management and oversight of QC testing and reporting performed at Contracted Manufacturing and Testing Organizations. This includes testing and ongoing stability of unique API starting materials, Drug Substance and Drug Product. Assist in all aspects of quality control in respect to clinical trial materials and commercial products as required. This position provides QC support to the Development, CMC, Operations, QA/QC and Regulatory Affairs departments.

Requirements

BS/BA in science related field or equivalent experience with 4+ years of related Quality Control experience in biotech or pharmaceutical position, particularly in a GMP environment
Ability to perform analytical methods, interpret and trend stability data including, but not limited to: Chromatography (IP-RP-UPLC/ SAX-HPLC/ GC) Mass Spec, FTIR, metals testing, residual solvents, vapor pressure and freezing point osmolality, UV, pH, endotoxin, sterility and bioburden
Knowledge of FDA cGMP regulations, ICH and FDA Guidances for Industry, Compendial requirements, other-country regulations and standards
Expertise in data analysis including reviewing, reporting and trending data.
Strong problem solving/analytical skills
The ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism
Excellent written and verbal communication skills, strong negotiation and decision-making skills and attention to detail are equally important
Strong organizational skills, with the ability to handle multiple tasks in a fast-paced environment

Responsibilities

Demonstrate technical proficiency in analytical methodology and ensure quality control activities are carried out according to and with adherence to regulatory and internal requirements, cGMP and ICH compliance
Create, revise, review and approve protocols, supporting analytical data and reports associated with method validation, testing and release of GMP starting materials, intermediates, Drug Substances and Drug Products
Serve as QC lead on analytical project teams and product operational teams
Conduct or support investigations regarding out-of-trend (OOT)/out-of-specification (OOS) results
Write/revise SOPs, technical protocols, change control and other quality related reports
Work with the Quality management team to continuously improve the quality, compliance and efficiency of QC operations
Effectively communicate internal issues related to performance, processes and procedures
Be a self-starting problem solver who drives results through high compliance and a positive work style