Manufacturing Associate I

Packaging Group Position

Shift: 1st Work Schedule: Monday - Friday 7am-3:30pm with occasionally O.T., starting at 6am and staying until 4:30pm

Description: The Packaging group, located at the Northborough Operations Center facility, is responsible for labeling and packaging of final drug product vials as finished product for sale and distribution to U.S., European and International markets in support of a global patient population. In the process of performing these functions, Packaging interacts with and receives support from the Quality Assurance, Materials Management, Facilities Engineering, Validation, Metrology and Manufacturing Technical Support groups. In addition, Packaging interacts with outside contractors, vendors, internal auditors and representatives of various Regulatory agencies.

Position Overview with Key Responsibilities

The candidate will interact with auto/manual equipment, set-up, changeover and clean various automated and manual packaging equipment in strict accordance with SOP's, Good Manufacturing Practices and Safety policies/procedures. Document production activities in batch records, log sheets, attachments and/or electronic Batch Records. Maintain sufficient inventory of packaging materials. Follow operational procedures and both written and verbal instructions from the supervisor/Manager. Perform manual packaging on an assembly line. Ability to lift up to 35 lbs. and move heavy objects (e.g., product vial cages, pallets of packaging materials). Ability to stand for 3 hours while manual packaging. Identify and communicate process deviations to the supervisor. Keep all training up to date and retrain prior to expiration date. Work with hazardous materials (e.g., Isopropyl Alcohol, Butanone). Work closely with various level manufacturing and support personnel in a dynamic and team-oriented environment. Routinely and safely handle high value product vials in various stages of packaging completion. Use computer-based systems for data collection, data analysis, timecards, e-mail and inventory management. Follow both written and verbal instructions from the supervisor/Manager. Periodically check and maintain flammables cabinet, satellite hazardous waste accumulation station. Optimizes automated packaging equipment for performance. This is a daytime position with occasional weekend work.

Basic Qualifications

High School Diploma / GED required 2-10 years working in Packaging and Good Documentation Practices Environment. Demonstrated basic math skills and communication skills. Basic mechanical skills. Experience using Word and Excel as well as ERP systems. Minimum 2+ years working in a packaging, or equivalent manufacturing environment.

Preferred Qualifications

Minimum 6 years working in a packaging, or equivalent manufacturing environment. Special Working Conditions Packaging operations require gowning consisting of hairnet, beard cover, lab coat, gloves, safety glasses, shoe covers and task specific personal protective equipment. Packaging operations require retrieval (and subsequent storage) of product vials from a 2- 8C cold room.