Associate Quality Technician

Job Title: Associate Quality Technician ((Identified candidates)

Location: Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The Associate Quality Technician will perform tasks by strictly adhering to Sanofi’s policies, procedures, and cGMP.  The candidate filling this position will work to ensure all tasks are completed in a timely and compliant manner.  The ability to handle multiple priorities (and respect timelines) is required to surpass milestones.  The ability to negotiate, work with and influence a variety of people in a positive manner while identifying, and working to solve problems is a requirement of the position.  The incumbent must be able to work effectively with colleagues at other Sanofi, contract sites, and outside vendors to ensure that GMP data is available in a timely manner.  This role is for a nonexempt employee working in the Quality Control Visual Inspection Materials Management (QCVIMM) Department.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Their responsibilities are, but are not limited to:

Safety

• Ensure proper personal protective equipment (PPE) is used in all areas that require it.

• Prepares for and operates QC equipment including pre and post run setup and maintenance.

• Attends/Contributes to scheduled team meetings, department meetings, and safety meetings.

• Ensure all Safety and compliance trainings are up to date.

• Maintains and identifies Improvement opportunities in the areas of laboratory safety and compliance. 

• Reports all safety issues, concerns, incidents and near misses to the team leadership.  (SOR)

• Works with the safety and leadership team to provide input for potential safety issues as well as contributing ideas, implement all safety initiatives by actively and effectively communicating the initiatives and by helping others to understand the initiatives.

• Works with the safety team to ensure that the resources required addressing safety issues are secured in a timely manner and that the effective resolutions are put into place and trained upon. 

Quality

• Strictly adhering to SOP, SWI, Federal Regulations, cGMP, training modules (when applicable), Sanofi policies and procedures and safety procedures.

• Identify issues/ trends related to processes, procedures, assays, and equipment.

• Performs peer verification.

• Ensure proper and correct documentation is documented at time of occurrence.

• Develop a working knowledge of appropriate compendia and/or regulatory guidance’s.

• Notifies laboratory manager of any deviations or issues and initiates incident investigations as required.

• Attention to detail in recording GMP data right first time into appropriate documents and systems. (Ex. Labware, MASTER, Yokogawa, etc.) 

Delivery

• Ensures product integrity by ensuring work orders are placed and issues are escalated to management in a timely manner.

•  Visual inspection of samples: (If applicable or manager assignment)

• • Acceptable Quality Limits (AQL)

  • Customer Complaints

  • Stability

  • Checks and Verifications

• Completes required paperwork and documentation in a timely manner.

• Troubleshoots sample discrepancies and communicates issues to proper areas and management.

• Proficiency and understanding of the theory behind System related functions:

• • SAP (Cycle counts, confirmations, inventories, etc.)

  • LIMs (inventories), etc.

  • MASTER

• Performs cleaning of laboratories, equipment, and ancillary areas as required, ensuring all duties are completed on time, in a safe and complaint manner.

Cost

• Adhere to current departmental metrics.

• Actively communicates improvement ideas, issues, concerns, etc. to team members along with providing solutions.

• Works to resolve common quality control issues related to area of work.

Involvement

• Ensure proper document review.

• Works on internal departmental projects as assigned by management.

• Ensures trainings are up to date in the current learning management system (LMS).

• Module/Assay training as assigned and offer suggestions for improvement.

• Professional/Technical development training on/ off-site as assigned.

Above responsibilities are not all comprehensive and are subject to change.  Any additional responsibilities not covered above is subject to manager assignment.  Due to the dynamics of the area, schedules are subject to change with appropriate adjustment periods.  All decisions are based on realistic business need.

Each individual working in a GMP area is responsible for following the documented processes and recording GMP data correctly.  It must be emphasized that non-compliance in following a GMP process or procedure may result in regulatory observations, up to and including recall, and a significant risk to the site’s continued operation.

About You  

• Requires strong mechanical, computer, comprehension, and retention skills, along with a strong attention to detail.

• Minimum of a HS Diploma/equivalent and 2 years prior cGMP, Quality Control, and experience with Labware LIMS and Master required.

• Vaccinations are required.

• 20/20 vision (with corrective eyewear as needed).

• Must possess knowledge of and access to systems in applicable buildings and processes.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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