100 Abbott Park Road Abbott Park, IL 60064
Voca has an immediate opening available for a QA Specialist in Abbott Park, IL!
- This position is NonExempt. Hours over 40 will be paid at Time and a Half. Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). BS degree or 3-7 years equivalent experience
- Primary Job Function:
Manufactures diagnostic assay components such as Antigen Fermentation/Purification; Tissue Culture; Solutions; Bulks; Micro particle Coatings; Conjugations; and/or Purifications. Manufactures in highly regulated specialized facilities using complex equipment and systems. Manufacturing and related activities must be documented with a high degree of accuracy and completeness. Uses Abbott manufacturing information systems (MES; AMM) while performing manufacturing process steps. Applies GMP; Bio burden reduction; and safety procedures. After completion of initial training; maintains at least one manufacturing certification.
Core Job Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
Manufactures diagnostic assay components in areas such as Antigen Production; Tissue Culture; Solutions; Bulks; Micro particle Coatings; Conjugations; and/or Purifications. Works with Potentially Bio hazardous or Bio hazardous Material using required Personal Protective Equipment (PPE). Performs routine maintenance and GMP activities while complying with GMP/ ISO requirements. Demonstrates knowledge and practical application of EHS policies; procedures and practices through personal work habits. Responsible for implementing and maintaining the effectiveness of the quality system. Applies basic computer skills including word processing; spreadsheets; instrumentation related; and Abbott network systems. Communicates effectively with coworkers and management. Understands critical areas impacting manufacturing: Problem Resolution; Corrective and Preventive Actions; Change Control; Error Reduction; Document Improvements; Safety; Process Improvements; new process implementation; Cost Containment and Control; Manufacturing Execution System (MES); GMP; Inventory Control; Compliance; Training and Skills Enhancement of others. Performs transactions in Manufacturing Execution System (MES) and Abbott Materials Management (AMM) and Work Order Tracking Tool (WOTT) Systems as required on time. Troubleshoots and resolves basic manufacturing problems and operational issues with assistance as necessary. Supports group/team activities and departmental goals. Obtains and maintains required manufacturing certifications. Uses supplies effectively and aware of material cost and limits waste. Develops knowledge of processes and technologies. Participates in identifying manufacturing documentation change control recommendations at a basic level.
Position Accountability / Scope:
Reports to Manufacturing Supervisor. Organizes and adapts daily/weekly activities to meet assigned manufacturing schedule. Assumes full accountability for quality and accuracy of processes; procedures; and documentation performed. Performs assigned tasks with supervision/guidance as required. Functions collaboratively in group settings. Highlights potential compliance or safety issues to area management. Cultivates relationships with coworkers and supervisor. Communicates effectively to coworkers and supervisor. Takes initiative to be involved in team activities and decision-making. Acquires knowledge and experience for continuous self-development. Support achievement of departmental initiatives and goals.
- Minimum Education:
Bachelor's degree in a related technical discipline preferred or 4+ years related experience (operations; manufacturing; production or lab).
Minimum Experience / Training Required:
Required knowledge/experience includes the following: Laboratory, verbal and written communication skills, basic scientific knowledge, basic mathematics, and basic computer skills.
Highly desirable experience includes participation in teams, GMP/ISO requirements and basic computer/data management. Solution/Chemical handling, Knowledge of regulations and standards affecting IVDs and Biologics
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