Abbvie, Inc Barceloneta , PR 00617
Posted 2 weeks ago
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
Responsible for the daily supervision and training of operating personnel in the Small Volume Parenteral area (SVP). Works in concert with other supervisors. Responsible for the accurate and timely completion of production related cGMP documentation. Responsible for implementation of manufacturing procedures. Ensures the effective use of material, equipment, and personnel in producing quality products.
Responsibilities
Reviews daily production schedule and priorities to determine unit (suite) assignments and critical actions.
Reviews all materials and batch records required to support shift and any off-shift needs for the day.
Provides on the floor training to support formalized technical and cGMP training. Checks that operator training files match and support the processes they are required to carry out.
Monitors operator training files and works with compliance specialist to keep files up to date.
Works with QA and Subject Matter Experts (Tech Ops or Process Sciences) to resolve exceptions.
Works with technology transfer team to incorporate new processes in the plant.
Reviews new Batch records and SOPs.
Provides supervision primarily to skilled nonexempt.
Evaluates staff performance.
Significant work activities:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
Work in a clean room environment
Qualifications
Requires a Bachelor's degree in Science or Engineering.
Requires between 2-4 years of experience in all aspects of manufacturing/ production processes (aseptic process knowledge & experience is highly preferred)
Previous experience supervising personnel is highly preferred.
Familiarity with industrial automation (e.g., distributed control and PLC-based systems).
Working knowledge of safety, quality systems, and cGMPs is required.
Candidate must be available to work on a 12 hours shifts and weekends.
Additional Information
Applicable only to applicants
Abbvie, Inc