Description:
Your Tasks And Responsibilities
- Visually inspect product vials for defects, media filled vials for evidence of contamination (turbidity), packaging components for quality;
- Follow all cGMPs, complete data recording contemporaneously in associated BPRs/EBRs and inventory management systems;
- Assemble product and components for packaging operation according to production schedule, bill of materials (BOMs), or instruction from the assistant supervisor or supervisor. Perform associated inventory adjustments and material movements in inventory management systems;
- Setup packaging line and equipment. Safely operate equipment for conducting packaging operations and packaging component preparation operations. Distribute components, supplies and product to packaging stations as needed to maintain packaging operations;
- Unload products from storage containers and examine for defect in container’s closure systems or product content. Check for correct lot information on product containers and components;
- Organize and remove product in and out of 2-8C cold rooms. Secure and store all in-process products and components in their proper areas. Move skids, transit trays, hand trucks and other containers of product, components, bottles, equipment or other items as required for efficient operation of the department. Seal, stack, and secure cases of packaged product on skids for transport to shipping department at the conclusion of packaging operations;
- Perform line clearances, count and reconcile product and components. Perform all functions in a safe and cGMP compliant manner (i.e. recording information in log books and BPR/EBRs);
- Cleans, inspects, and maintains production equipment/facilities;
- Performs in-depth troubleshooting and root cause analysis of equipment and makes necessary adjustments (if necessary) to reduce process/equipment failures;
- Contributes to continuous improvement opportunities;
- Perform other related duties as assigned.
Who You Are
Bayer seeks an incumbent who possesses the following:
Required Qualifications
- Requires high school diploma, or GED;
- Read, write, speak, and comprehend English in order to understand written and verbal instructions, SOP’s, BPR’s, etc.;
- Good verbal and written communication skills;
- Work weekends, holidays and overtime as required;
- Acceptable attendance and performance;
- Effectively work both independently and in a team environment;
- Basic computer skills;
- Able to perform basic math functions (add, subtract, multiply, and divide);
- SAP knowledge and proficiency in writing and execution of SAP notifications;
- Pass initial and annual inspection qualification trials;
- Maintain output at established line speeds (6-9 secs/vial);
- Monitor and maintain housekeeping in work areas in accordance with cGMP;
- Trained and qualified to prepare cleaning solutions as needed.
Preferred Qualifications
- Experience operating automated equipment;
- Lift/carry up to ≤50 lbs. and push/pull up to ≤300 lbs. with assistance;
- Withstand standing and/or sitting for extended periods of time (up to an entire shift);
- Withstand repetitive hand/wrist motions, bending, twisting;
- Be able to squat, bend at waist, and reach above head for extended periods of time;
- Pass initial and annual vision exam;
- Work without wearing heavy makeup and/or hand lotion;
- Identify color-coded labels.
- Wear protective clothing as required, including: latex, nitrile, or cotton gloves;
- Work in an atmosphere that can/will have some dust, corrugated materials, and chemicals.