AbbVie

Operations ER Writer

Employer
AbbVie
Location
Worcester, Massachusetts
Posted
Jun 12, 2021
Ref
2109692
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

  • Investigates deviation from manufacturing procedures and processes. 
  • Documents investigations and CAPAs.
  • Drafts broad scope and complexity documents. Circulates the documents to reviewers and without assistance responds to comments and questions. Manages document review and approval to meet project timelines.
  • Tracks ongoing challenges and gathers information for analysis. Uses analysis to develop solutions. Presents potential solutions to management and senior personnel, and with limited assistance creates an implementation plan.
  • Drive sustainable CAPAs to enable a reduction in deviations.
  • Evaluates data for trends, which may impact other systems, projects, or areas.
  • Applies knowledge, experience, and technical skills to understand production objectives and evaluate potential changes, implement production initiatives.
  • Executes systems and procedures efficiently and compliantly and evaluates systems for improvement potential. Develops and uses standard practices to ensure inter-group consistency.
  • Flexibility with working remotely.

Qualifications
  • Bachelor’s Degree or equivalent required.
  • At least 8 years’ experience in all aspects of manufacturing and production processes.
  • Knowledge of biologics manufacturing; computer expertise; in-depth knowledge of safety, quality systems, and current Good Manufacturing Practice is required.
  • Experience with TrackWise or similar system is preferred.
  • Must be flexible to handle multiple tasks including ability to handle pressure in a professional and positive manner; Effectively works in a team environment; Maintains high level of energy and professionalism on the job; Builds effective working relationships with customers, co-workers, cross-functional groups and management.
  • Uses problem solving skills when working on complex problems, where analysis of situations requires an in-depth evaluation of various factors.
  • Uses discretion and works independently; follows established procedures. Decisions are reviewed for soundness of technical judgment. Independently decides when to make minor adaptations or modifications.
  • Coordinates the completion of daily operational activities across a unit or sub-unit. Decisions, recommendations and actions contribute to the development of suite schedules and personnel allocation.
  • Provides technical direction and training to less senior personnel; Coordinates activities of sub-group and actively works with other sub-groups. Acts as advisor to unit or sub-unit becomes actively involved as required. Provides technical direction and training to less senior personnel. Participates in technical investigations and provides on the floor technical expertise; Provides a motivational and team building atmosphere. Acts as a mentor.
  • Frequently interacts with subordinates or functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc. Regularly discusses progress, problems, and proposed solutions with colleagues and senior personnel.
  • Detailed understanding of current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility. Able to make recommendations for improved compliance at plant level. In-depth knowledge of pertinent regulatory filings.

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.