Batch Record Reviewer

Philip Morris International • Aurora, CO

21h • $33 • Onsite

About The Position

Be a part of a revolutionary change! At Philip Morris International (PMI), we’ve chosen to do something incredible. We’re totally transforming our business and building our future on one clear purpose – to deliver a smoke-free future. With huge change, comes huge opportunity. So, if you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions. Our success depends on people who are committed to our purpose and have an appetite for progress. Your ‘day to day’: Perform critical review of executed batch production records while managing intermediate and finished product nonconformities and related corrective and preventive actions held and ultimately confirms to the final approver that the product can be released for commercial manufacturing. Provide reports and technical support to relevant departments related to quality performance and assessment of the product quality in line with QMS procedures. Major Responsibilities and Accountabilities The Accountabilities/Essential Job Functions of this position are not limited to the following list. Other functions may be assigned as necessary. The Company retains the discretion to add to, eliminate, or change the duties of the job description at any time. Ensure Compliance and Safety Guarantee adherence to PMI and legal standards, policies, and environmental, Health, Safety, and Sustainability guidelines. Foster a proactive, safety-first culture using preventive and predictive approaches in line with our Integrated Operating System. Batch Record Documentation & Analyze & Reporting Support the manufacturing team in the establishment and revision of the batch documentation, providing guidance on data and record management. Ensure manufacturing batch record and batch release documentation is accurate, complete, reviewed and archived in line with PMI guidelines and QMS requirements to ensure confirmation that the product can be released for commercial manufacturing . Provide support on report generation and data analysis, when required by ensuring the compliance and integrity of data. Participate/support the monitoring of the different Quality Key Performance Indicators (KPI). Nonconformities & CAPA Management Establish a system to identify and segregate all non-conforming intermediate and finished products whether identified at warehouse, at laboratory, on the floor or post-production. Investigate and resolve critical deviations, define disposal actions and when appropriate, corrective actions. Define and implement a monitoring system of manufactured products through appropriate historical data and trend analysis to identify potential deviations and preventive actions (CAPA). Quality Support Provide Quality support and expertise to improve products and Quality systems. Ensure timely quality support in case of any quality problems encountered on products, providing quality risk assessment and an accurate action plan/solution that immediately reduces the negative impact on the Quality and production KPI's. Provide on-floor support in the implementation of quality standards and self-control system in order to ensure that the products and the processes meet the quality requirements all along the manufacturing line. COMMUNICATION & COOPERATION Communicate all useful information for the good flow of Quality processes to concerned colleagues and to support teams in order to meet productivity and quality. Provide support during product and process improvement tests and new platform development. Support Quality Engineers to define new quality standards for new products. TRAINING Execute internal training to manufacturing employees, as a subject matter expert in quality process and products, in order to enhance their overall level of quality awareness.

Requirements

• Degree in Biological sciences, Physical sciences, Engineering or equivalent skills through demonstrated experience.
• 2+ years’ experience in FMCG production, quality or relevant skills through demonstrated experience.
• Experience working with manufacturing batch record documentation.
• Essential to be a team player with excellent communication skills and patience with others.
• Knowledge of quality systems, data review, attention to details.
• Advanced knowledge of Quality tools, root cause analysis, analytical skills, statistical tool knowledge.
• Ability to transform data into information (reporting skills).
• Knowledge of International Standards (ISO) and FDA cGMP requirements.
• Experience in FDA regulated environment is preferred.

Responsibilities

• Perform critical review of executed batch production records while managing intermediate and finished product nonconformities and related corrective and preventive actions held and ultimately confirms to the final approver that the product can be released for commercial manufacturing.
• Provide reports and technical support to relevant departments related to quality performance and assessment of the product quality in line with QMS procedures.
• Ensure Compliance and Safety Guarantee adherence to PMI and legal standards, policies, and environmental, Health, Safety, and Sustainability guidelines.
• Foster a proactive, safety-first culture using preventive and predictive approaches in line with our Integrated Operating System.
• Support the manufacturing team in the establishment and revision of the batch documentation, providing guidance on data and record management.
• Ensure manufacturing batch record and batch release documentation is accurate, complete, reviewed and archived in line with PMI guidelines and QMS requirements to ensure confirmation that the product can be released for commercial manufacturing .
• Provide support on report generation and data analysis, when required by ensuring the compliance and integrity of data.
• Participate/support the monitoring of the different Quality Key Performance Indicators (KPI).
• Establish a system to identify and segregate all non-conforming intermediate and finished products whether identified at warehouse, at laboratory, on the floor or post-production.
• Investigate and resolve critical deviations, define disposal actions and when appropriate, corrective actions.
• Define and implement a monitoring system of manufactured products through appropriate historical data and trend analysis to identify potential deviations and preventive actions (CAPA).
• Provide Quality support and expertise to improve products and Quality systems.
• Ensure timely quality support in case of any quality problems encountered on products, providing quality risk assessment and an accurate action plan/solution that immediately reduces the negative impact on the Quality and production KPI's.
• Provide on-floor support in the implementation of quality standards and self-control system in order to ensure that the products and the processes meet the quality requirements all along the manufacturing line.
• Communicate all useful information for the good flow of Quality processes to concerned colleagues and to support teams in order to meet productivity and quality.
• Provide support during product and process improvement tests and new platform development.
• Support Quality Engineers to define new quality standards for new products.
• Execute internal training to manufacturing employees, as a subject matter expert in quality process and products, in order to enhance their overall level of quality awareness.

Benefits

• We offer employees a competitive base salary and the potential to receive a discretionary annual bonus.
• Employees (and their families) also have the option to enroll in our company medical, dental and vision plans.
• The company offers flexible spending accounts for health care and dependent care, as well as health savings accounts for those that choose to enroll in a high deductible health plan (HDHP).
• Employees are auto-enrolled in our company’s 401(k)/Deferred Profit Sharing (DPS) Plan, which provides for both annual 5% employer matching contribution and an annual employer contribution.
• As a new hire, you will enjoy an allotment of paid vacation time, paid sick time, 12 paid company holidays, and 3 paid floating holidays.
• We also provide our employees with paid parental leave, paid family and medical leave, paid bereavement leave, paid sick and safe time, paid public emergency leave, paid time off for jury duty, and paid time off for certain activities relating to their status as a victim of domestic violence, sexual assault, stalking, or crime.
• The company offers unpaid national guard and reserve leave, unpaid civil air patrol leave, unpaid qualified volunteer leave, and unpaid time off for employees engaging in certain activities relating to criminal proceedings.
• The company also provides basic life insurance, accidental death & dismemberment (AD&D) insurance, and short-term and long-term disability insurance to employees at no cost.
• Employees have the option to purchase supplemental life and AD&D coverage for themselves, spouse, and dependent children.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level