Quality Technician

Quality Technician

Who we are?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients' lives to as many people as possible.

With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.

Your role

Reporting to the Quality Systems Manager,

The Quality Systems Technician is responsible for monitoring and reporting all aspects of the site's Pharmaceutical Quality Management System including Key Performance Indicators (KPI's), Annual Product Reviews, CAPA Tracking and Recurrence for Deviations and Complaints, and tracking of Change Control action items. This position will support regulatory agency and customer audits by facilitating the "back room" activities, assisting in the audit responses, and tracking all CAPA's associated with the responses. In addition, Quality Systems Technicians will support on-going continuous improvement activities of the site's Pharmaceutical Quality System.

DUTIES / RESPONSIBILITIES:

Report Key Performance Quality Metrics

Provide weekly KPI metrics for Site Leadership review. Metrics may include deviation, CAPA, and Right First Time, etc.

Supply required information for the Quarterly Quality Review meeting and presentation.

Manage CAPAs related to deviations and customer complaints.

Manage the progress of CAPAs, utilizing TrackWise. Work with CAPA owners through meetings or one on one work sessions to ensure CAPAs progress through closure by the required due date.

Analyze and document impact of CAPA's not completed on time.

Ensure closure of CAPAs and identification and verification of CAPA effectiveness checks.

Recurrence analysis of deviations/customer complaints and identify areas for improvement.

Analyze customer deviations/complaints on a monthly basis and present the different recurrences over the last three months for the Quarterly Quality Review meeting and presentation.

Facilitate improvement work meetings and propose improvement actions

Author Annual Product Review Reports

Draft Annual Product Review Reports by the required customer due dates.

Collect and analyze the data, ensure the consistency of the data, facilitate any applicable statistical analysis and implementation of improvement areas.

Coordinate the Annual Product Review Reports review and approval process.

Communicate with the customer and ensure all comments are addressed for final approved document.

Propose and implement areas for improvement related to the Annual Review Process.

Participate in Continuous Improvement Processes at the site.

Lead working groups or site improvement projects.

Execute improvement actions (document updates, batch card updates, forms, etc.)

Ensure compliance with regulatory, customer and quality requirements within the various working groups

Complete assigned actions by required due dates.

QA/compliance experience in manufacturing, facility operation, laboratory compliance and quality systems.Experience in supporting regulatory inspections. Good teamwork and project management skills (including the ability to lead teams).Requires excellent communication, interpersonal and organization skills.

Must be able to recognize situations where there is a potential impact on product quality, safety, identity and purity. Encourages self and others to consider innovative approaches to addressing problems and developing solutions that are effective and compliant.Responsible for developing and ensuring full implementation of an appropriate solution.

Your profile

B.A./B.S. Chemistry, Biology, Pharmacy, Health Science or Related Field

A minimum 3 years Quality Assurance experience in FDA regulated environment is preferred.

Degree requirement may be substituted with an appropriate level of Quality Assurance experience inFDA regulated environment at an equivalent level.

Familiarity with EnnovDoc and/or TrackWise preferred.

Ability to work autonomously using established procedures, seeking guidance where needed.

Self-motivated and demonstrated ability to learn and work in a fast-paces environment where multiple concurrent projects must be completed in a timely manner.

Experience in audits and regulatory inspections a plus

Compensation range

27.00 - 31.00 USD

• The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Learn more about us:

We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.

Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.

We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.

We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.

Join us and make a difference!