GMP Cleaning Manufacturing Associate (Wed-Sat, 2Nd Shift, 4Pm - 2:30Am)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Purpose

Performs functions associated with current Good Manufacturing Practices manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components and final materials. Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment. Determines and may assist in developing methods and procedures to control or modify the manufacturing process.

Responsibilities

• Create, maintain and archive GMP cleaning documentation both physical and electronic.

• Maintain GMP cleaning personnel training and qualifications. Ability to perform instructor lead classes and qualifications in an individual or group setting.

• Observe GMP cleaning activities. Applies knowledge to drive performance.

• Transfers methods into Production instructions to allow for successful performance of scheduled campaigns.

• Schedules work tasks, with general assistance, to support project and campaign timelines. Drafts moderate scope and complexity documents. Circulates documents to reviewers with general assistance, responds to comments and questions. Manages document review and approval to meet project timelines and provides status reports to management.

• Works with management and senior staff to determine appropriate course of action within defined procedures. Tracks ongoing problems and gathers information for analysis. Analyzes data to develop solutions to moderate-level problems.

• Applies knowledge, experience, and technical skills to understand ABC production objectives, to provide support to production initiatives, to execute procedures efficiently and compliantly, and use standard practices to ensure inter-group consistency.

• Works on problems of moderate complexity, where analysis of situations requires evaluation of several factors.

• Exercises judgment within defined procedures and policies to determine appropriate action. Discusses action with senior staff.

• Coordinates activities of sub-group and actively works with other sub-groups. Frequently interacts with subordinates and supervisor.

Qualifications

• Bachelor's Degree or equivalent required.

• At least 2-5 years relevant experience with good writing skills.

• Working knowledge of manufacturing area cleaning, media/buffer preparation, cell culture or purification of biological drugs is required.

• Computer proficiency. A working knowledge of safety, quality systems, and current Good Manufacturing Practices is required. Familiarity with tech transfer processes.

• Must be flexible to handle multiple tasks including ability to handle pressure in a professional manner. Effectively work in a team environment. Maintain a high level of energy and professionalism on the job. Build effective working relationships with customers, co-workers, cross-functioned groups, and management.

• Basic understanding of current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility.

Additional Information

Applicable only to applicants