Associate Quality Engineer

Endo Pharmaceuticals

Horsham,PA  

2019-11-12 2019-12-12
engineer quality allied.health administration pharma

Endo International plc is a global specialty pharmaceutical company focused on improving patients' lives while creating value. Endo develops, manufactures, markets and distributes quality branded pharmaceutical and generic pharmaceutical products as well as over-the-counter medications through its operating companies.

Endo has global headquarters in Dublin, Ireland and U.S. headquarters in Malvern, PA. We believe in making a difference, and the dedication and experience of our employees guide that aspiration. Both our company and the growth of our individuals are driven by a common purpose – to deliver therapies that make a significant, positive impact on patients' lives.









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







Accountability



Responsibilities



% 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



40%







Analysis



§ 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.)



30%







Compliance



§ 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



25%







Metrics



§ Tabulates defined department/site metrics and reports to departmental management



5%







Total



100%















Qualifications







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







Knowledge



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























Skills



&



Abilities



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 Requirements



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.

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