Sanofi Group Labeling Technician- Malvern, PA in Malvern, Pennsylvania
The Labeling Technician role is intended to lead or participate in clinical label design, generation of clinical labels, inspection of clinical labels, verification and documentation of labeling processes to support primary packaging, secondary packaging, assembly of investigation product (IP), and warehouse activities for domestic and international clinical trials for the Great Valley, Clinical Supplies SCP.
The incumbent is required to produce high quality clinical labels that are fit for purpose and right first time with minimum supervision required. He/she must be able to ensure work of others is in compliance to established producers and policies. The incumbent must accurately document information relative to the generation of clinical labels in accordance with cGMPs and departmental SOPs.
The incumbent is required to identify deviations and problems to supervision. He/she must assist in conduction investigations, assessment of options and implementation of solutions in order to maintain a fully compliant operation with CS SCP under general supervision.
Major Duties and Responsibilities
He/she must participate in the set-up, operation, cleaning, validation/qualification of labeling equipment as required under cGMPs and by company SOPs.
Lead or participate in clinical label design, generation of clinical labels, inspection of clinical labels, verification and documentation of labeling processes and other related labeling operations.
Be compliant with established procedures, policies, and regulations. Identify any operational deviations and notify the appropriate supervision. Assist in conducting investigations, assessment of options and implementation of solutions in order to maintain a fully compliant operation with CS SCP.
Accurate completion of appropriate documentation relative to the creation and generation of clinical labels in accordance with cGMPs and departmental SOPs. This is to include the verification of the work and documentation of other staff members.
Must become proficient with and employ the departmental computerized inventory system (NASCA) for all labeling activity. Position will require proficiency with CODESOFT for clinical label design.
Support the implementation of improvements in quality, productivity, regulatory compliance, cost effectiveness, and safety.
Participate in the training of packaging staff on procedures, label production process, equipment operation and SOPs.
Conduct first review of label print records as appropriate. Lead or participate in the set-up of label production equipment as required. Take part in trouble shooting activity as appropriate.
High School diploma or equivalent is required.
Two years of experience in the pharmaceutical industry, preferably in label creation and generation.
Excellent communication, problem solving, and prioritization skills.
Knowledge of clinical labeling and packaging, shipping and other regulatory requirements as they pertain to clinical supplies.
Proficiency in Microsoft suite of applications; Outlook, Word, PowerPoint and Excel.
Experience in label creation and generation software is an asset.
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
Sanofi, Empowering Life