Sanofi Group Tech Clinical Supplies Packaging in Malvern, Pennsylvania

Tech Clinical Supplies Packaging

Description

Sanofi, a global healthcareleader, discovers, develops and distributes therapeutic solutions focused onpatients’ needs. Sanofi has core strengths in diabetes solutions, humanvaccines, innovative drugs, consumer healthcare, emerging markets, animalhealth and Genzyme.

Sanofi US

At Sanofi US, we are committed to the growth of our people,connected in purpose by career, life and health.

Headquartered in Bridgewater, NJ, Sanofi US is part of a leadingglobal healthcare company dedicated to discovering, developing and distributingtherapeutic solutions focused on patients’ needs.

Sanofi has core strengths in diabetes solutions, human vaccines,innovative drugs, consumer healthcare, emerging markets, animal health andGenzyme.

Sanofi US employs approximately 17,000 people across the country alldedicated to protecting health, enhancing life and responding to the hopes andpotential healthcare needs of seven billion people around the world.

Commitment is our Strength. Ready to grow together?

Sanofi US endeavors to makeour career center accessible to any and all users. If you are experiencingdifficulty and need assistance applying online, please call 1-800-207-8049Option 7, then Option 3.

Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity andAffirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment withoutregard 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 violencevictim status; atypical cellular or blood trait; genetic information (includingthe refusal to submit to genetic testing) or any other characteristic protectedby law.

Technician,Clinical Supplies Packaging

The Technician, Clinical Supplies Packaging leads orparticipates in primary packaging, secondary packaging and assembly ofinvestigational products (IP), participates in warehousing activity, clinicallabel design and generation (if applicable) for domestic and internationalclinical trials for the Great Valley, Clinical Supplies SCP.

The technician is required to produces high qualityIP with general supervision. He/she must be able to ensure work of others is incompliance to established procedures and policies. The technician mustaccurately document information relative to preparation, packaging, andshipping of clinical supplies in accordance with cGMP’s and departmental SOP’s.

The technician is required to identify deviationsand problems to supervision. You will also assist in conducting investigations,assessment of options and implementation of solutions in order to maintain afully compliant operation within CS SCP under general supervision.

He/she must participate in the set-up, operation,cleaning, validation/qualification of packaging equipment as required undercGMPs and by company SOPs

Duties/Responsibilities:

  • Lead or participate in primarypackaging, secondary packaging and assembly of investigational product (IP) andwarehousing activity for domestic and international clinical trials. Positionmay include clinical label design and generation

  • Compliance with established procedures,policies, and regulations. Identify any operational deviations and notify theappropriate supervision. Assist in conducting investigations, assessment ofoptions and implementation of solutions in order to maintain a fully compliantoperation within CS SCP

  • Accurate completion of appropriatedocumentation relative to the preparation, packaging, and shipping of clinicalsupplies in accordance with cGMPs and departmental SOPs. This is to include theverification of the work and documentation of other staff members

  • Must become proficient with and employthe departmental computerized inventory system (NASCA) for all packagingactivity. Position may also require proficiency with CODESOFT for clinicallabel design

  • Support the implementation ofimprovements in quality, productivity, regulatory compliance, costeffectiveness, and safety

  • Participate in the training of packagingstaff on procedures, equipment operation and SOPs. Assist in the coordinationand assignment of temporary staff to packaging operations

  • Ensure all IP produced is compliant byfollowing the packaging instructions, employing in-process controls andaccurate completion of the batch records. Conduct first review of batch recordsas appropriate. Lead or participate in the set-up of packaging equipment. Takepart in any trouble shooting activity as appropriate

Qualifications

Required Education/Experience

  • High school diploma or equivalent isrequired

  • Minimum two years of experience in thePharmaceutical industry

  • Familiarity with Good Manufacturing Practices (GMPs)and/or standard procedures for a pharmaceutical packaging or manufacturingoperation

  • Proficiency in Microsoft suite ofapplications; Outlook, Word, PowerPoint and Excel

Preferred Experience

  • Knowledge of clinical labeling andpackaging, shipping and other regulatory requirements as they pertain toclinical supplies.

#LI-SA

Job: Supply Chain

Primary Location: United States-Pennsylvania-Malvern

Job Posting: Dec 1, 2016, 5:15:52 PM

Job Type: Regular

Employee Status: Regular