Please note this is a 1 year contract position.
Qualifications: Generally requires (4-6) years related experience Responsibilities: Responsible for using equipment for the assembly and processing tasks to produce finished products according to established specifications. Accountable for adhering to all quality and safety guidelines. Comments/Special Instructions Looking for Temp to work day shift on a 12 hour rotating shift 6am - 6pm (Monday, Tuesday, Saturday, Sunday one week then Wednesday, Thursday, Friday the next week), then repeat.
POSITION SUMMARY :
This position is responsible for performing manufacturing procedures and executing diverse tasks in various manufacturing areas related to Filling, Labeling and Line Tending in areas such as BioVue, Gel, Donor Screening ELISA Plate processing, RhoGAM Filling, Label Control and Reprographics according to detailed operational specifications and execution of scheduled tasks within a cGMP environment. Ensure materials are available to meet production schedule. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations. Accountable for adhering to all EHS guidelines.
*ESSENTIAL FUNCTIONS :
- Execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.
- Support schedule adjustments to meet production, material receipt and shipping requirements.
- Work with Shift Leader//Team Leader to review departmental production schedules, work orders and related information to ensure materials are available for production.
- Maintain working knowledge of cGMP requirements to ensure adherence to compliance policies and regulations
- Sets up and operates production equipment to produce work in process and finished goods
- Perform in-process testing as required by processes and procedures utilizing equipment such as: (Fillers, Labelers, Gel line, BioVUE line, ELISA plate equipment and pouchers, autoclave, oven, torque testers, scales and printers) list is not all inclusive
- Check products on line to confirm proper assembly and remove defective products
- Take samples for further downstream testing and perform tests during processing according to standard procedures
- Use of ERP system for performing material transactions/moves/quantities/cycle counts
- Cleans, maintains, and performs basic repairs on equipment as needed
- Operate and troubleshoot equipment in clean room and non-clean room environment
- Assure manufacturing facility and equipment meets all requirements prior to production on all shifts.
- Accurately complete documentation in batch records, logbooks, forms and other GMP documents.
- Verify and enter production parameters per SOP and Batch Records.
- Monitor environmental conditions inside and outside classified rooms
- Wear the appropriate PPE when working in manufacturing and other working environments.
- Demonstrate training progression, train designated personnel in all levels of responsibility
- Review specifications and keep them up to current standards and practice and revise when necessary.
- Understand Lean principles as it relates to work
- Understand Value Stream maps and relevancy
- Actively participates in Kaizen, problem solving and asset care
- Proactively maintain a clean and safe work environment by performing sanitizing and housekeeping duties and looks for opportunities to improve. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors
*ADDITIONAL RESPONSIBILITIES/DUTIES :
- Offer suggestions and follow up on process improvements related to safety, compliance, cost, yield and productivity.
- Carry out duties in compliance with all state and federal regulations and guidelines including FDA, TUV, EPA and OSHA.
- Adhere to the safety code of Conduct & J&J EHS policies and attend all required EHS training.
- Follow Global Leadership Profile (GLP) competencies based on their leadership level within the organization (individual leader)
Support the ongoing production schedule by:
- Report to work on-time and according to the shift schedule.
- Perform other duties as assigned.
- Attend departmental and other scheduled meetings.
- Practice good interpersonal and communication skills.
- Demonstrate positive team-oriented approach in the daily execution of procedures.
- Promote and work within a team environment
- Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
- Assist with validation activities in the area
- Responsible for audit preparation and participation
- Recognize, open, write and review non-conformances
*This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.
Please reference job number 1540.