Senior Quality Engineer

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

Job Description Summary

The Senior Quality Engineer is responsible for facilitating full investigation of deviations and non-compliance issues encountered during pharmaceutical processing, handling and operation. This position will also oversee the review of corrective and preventative action (CAPA) plans to assure completion. This position also requires review and approval of protocols and associated documents. This position supports the site Product Scorecard program by serving as a Subject Matter Expert (SME) on Statistical Analysis and product trending.

Job Description

Job Title: Senior Quality Engineer

Company: Endo Ventures

Function: Quality

Location(s): Dublin, Ireland

Department: Quality Engineering

Direct Reports (list): N/A

Reports to (title): Manager/Sr. Manager

Date Submitted: 9/30/2019

To be completed by Corporate Compensation:

Job Code: J04518

Band: C

Date Reviewed: 9/30/2019

Benchmark: AZE030-P3-12

EEO: --

FLSA (USA only): --

Job Summary - a concise overview of the job

The Senior Quality Engineer is responsible for facilitating full investigation of deviations and non-compliance issues encountered during pharmaceutical processing, handling and operation. This position will also oversee the review of corrective and preventative action (CAPA) plans to assure completion. This position also requires review and approval of protocols and associated documents. This position supports the site Product Scorecard program by serving as a Subject Matter Expert (SME) on Statistical Analysis and product trending.

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.

Endo Ventures

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability - Deviation Investigations

Responsibilities:

• Responsible for guidance/facilitation of investigation process for manufacturing process deviations.
• Reviews and approves deviations; Ensures that investigations have identified root cause and the appropriate corrective and preventive actions.
• Leads project teams and uses quality engineering tools to support investigations, corrective actions, continuous improvement projects, and process capability improvements.
• Independently collaborates across departments to ensure all quality aspects of validation and qualification activities at the site including process validation, packaging validation, computer validation (URS), IQ, OQ and PQ.
• QA review and approval of delay justifications for investigations that will not meet/have exceeded their established due date.

% of Time - 60%

Accountability -CAPA Planning

Responsibilities:

• Facilitates meaningful CAPA plan with the responsible parties, including reasonable completion dates.
• QA review and approval of delay justifications for CAPAs that will not meet/have exceeded their established due date.

% of Time - 35%

Accountability -Other Duties

Responsibilities:

• Reviews and approves protocols and reports.
• Compiles and prepares investigation and CAPA metrics for monthly Quality Review Board meetings, Monthly CAPA meetings and weekly business review meetings.
• Supports Product Scorecard program by serving as an SME for statistical analysis / product trending.

% of Time - 5%

Total - 100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

• Bachelor’s degree in Engineering, Science, or related discipline with a minimum of 5-8 years’ relevant experience OR
• Master’s degree in above disciplines with a minimum of 3-6 years’ relevant experience OR
• PhD with a minimum of 0-3 years’ relevant experience.
• Must possess a solid background in statistical analysis; demonstrate proficiency with use of statistical software such as JMP, Minitab, etc.

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.

• Thorough knowledge of statistics, failure modes and effects analysis, root cause analysis, process mapping, statistical process control, design of experiments, and other related engineering tools.
• Requires an individual well versed in cGMPs; floor operations; solid understanding of manufacturing operation.

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 lead teams.
• Ability to coach personnel across departments and to mentor other Quality Engineers.
• Ability to display and analyze data in a logical manner.
• Good communication skills, including reading and understanding technical instructions.
• Ability to take initiative, set priorities and follow through on assignments.
• Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge/skills; shares expertise with others.
• Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
• Quantity - Meets productivity standards; completes work in timely manner; strives to increase productivity; works quickly.
• Adaptability - Adapts to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, or unexpected events.
• Dependability - Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan.
• Initiative - Volunteers readily; undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed.
• Professionalism - Approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
• Teamwork - Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; able to build morale and group commitments to goals and objectives; supports everyone's efforts to succeed.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings.
• Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.

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.

• The noise level in the work environment is usually moderate

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.

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.