Job Summary - a concise overview of the job
The Associate Quality Engineer is responsible for supporting and assisting with review and oversight of validation and qualification activities, performing various types of analysis and assisting with internal investigations, CAPA, and change controls.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Typically works with a single site and has no monetary budget authority
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Validation & Qualification
§ Supports validation and qualification activities at the site including process validation, computer validation (URS), IQ, OQ and PQ
§ Reviews equipment qualification protocols
§ Uses quality engineering tools to conduct data analysis
§ Performs statistical analysis for the identification of trends
§ With guidance, provides support for investigations, corrective actions, continuous improvement projects, and process capability improvements (FMEA, root cause analysis, process mapping, Six Sigma, SPC, DOE, etc.)
§ With guidance, assists departments to ensure compliance with cGMPs (e.g. change controls, SOPs, CAPAs, investigation etc.)
§ Reviews engineering Change Controls
§ Recommends revisions to department SOPs that are in compliance with FDA and other regulatory requirements and guidances
§ Tabulates defined department/site metrics and reports to departmental management
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ BS in Engineering, Science, or equivalent and a minimum of 0-1+ years of relevant experience
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Knowledge of statistics, failure modes and effects analysis, root cause analysis, process mapping , statistical process control, design of experiments, and other related engineering tools
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Ability to display and analyze data in a logical manner
§ Good communication skills, including reading and understanding technical instructions
§ Good attention to detail
§ Solid organizational skills
§ Ability to take initiative, set priorities and follow through on assignments
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Ability to wear personal protective equipment, including respirators, gloves, etc.
§ Manual dexterity
§ Ability to lift and carry 15 lbs
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.