AbbVie Biology Validation Specialist Vacancy 2022 – Apply Online
The successful candidate will be responsible for conceiving, designing, and executing robust in vitro studies and delivering high-quality data. In this role, he/she will work closely with colleagues and members of the Therapeutic Platform Teams to implement in vitro assay strategies and mechanistic studies as part of the overall project plan
Job Title: Specialist, Validation QA
Location: Lake County, Illinois
Req ID 2211890
Category Quality Assurance
Qualifications:
List required and preferred qualifications (up to 10). Include education, skills and experience.
โขBachelor’s Degree Required (preferably in Biology, Chemistry or Engineering)
โข6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
โขStrong verbal and written communication skills
โขSolid problem solving and analytical skills
โขSolid interpersonal skills, including ability to negotiate/influence without authority
โขAbility to supervise junior or contract team members (prior supervisory experience preferred)
โขAbility to manage complex projects and multiple projects (5+) simultaneously
โขKnowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
Responsibilities:
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
โขResponsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements
โขEnsures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility
โขExecutes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended
โขEnsures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy
โขParticipates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation
โขMay supervise contract validation resources in the timely completion of activities in his/her area of responsibility
โขMay lead, author, or review investigations and implementation of preventive and corrective action
AbbVie Biology Validation Specialist
