Quality Compliance Specialist III (t272)

  • Contract Duration: 6 Months with potential to extend
  • Manufacturing
  • Brooklyn Park, IL

Website Lenox Executive Search

6 months to start with the possibility of extension

OBJECTIVES:
•       Support Quality Compliance activities associated with Commercial cGMP biologics drug substance operations through internal/regulatory body audits, document review and interactions with site personnel.
•       Support site personnel performing deviation investigations, CAPAs and change controls through knowledge of quality concepts, investigational techniques and root cause analysis.

RESPONSIBILITIES:
•       Regularly work cross-functionally with other departments and may also interact with other company sites and/or Brooklyn Park suppliers to ensure global compliance and consistency.
•       Support application of quality compliance by aligning daily responsibilities with the appropriate cGMP regulations for US, EU and Japan.
•       Support analyses of manufacturing-related quality metrics to identify risks, improvement opportunities and/or compliance concerns. Support resolutions to conclusion by supporting continuous improvement initiatives.
•       Support logistic activities related to the Quality Self-Assessment program and execute assessments with guidance from Quality Compliance management.
•       QA support on corrective actions resulting from self-assessments or inspection readiness activities.
•       Support during all internal or regulatory audits/inspections of Quality & Operations departments.
•       Perform weekly monitoring and updates to quality systems for any adverse compliance trends and escalate any risks to manager.
•       May identify regulatory issues and trends and escalate to manager, as appropriate.
•       Receives minimal supervision on routine work assignments. Receives specific instruction on new work.
•       Complete mandatory training within required timeframe.
•       Additional tasks and duties as assigned.

REQUIREMENTS:
•       Bachelor’s degree in Life Sciences and 3-5 years’ experience in a regulated industry preferred.
•       Master’s degree in Life Sciences with 0-2 years’ experience in a regulated industry a plus.
•       Knowledge of cGMP regulations for US, EU and other markets.
•       Must be detail-oriented and have effective time management skills.,.
•       Excellent interpersonal skills and the ability to work effectively and efficiently in a team environment.
•       Must be able to clearly and effectively present to all levels of the organization
•       Excellent organizational skills
•       Proficient computer, verbal and written communication skills.
•       Strong problem solving and data analysis skills.
•       Drives results

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