QA Specialist II

Job Description We are seeking a highly motivated individual to join us as a Quality Assurance Specialist II. In this role you will be responsible for executing a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. The standard work week for this position is M-F, however weekend/night work will be required during manufacturing campaigns to support process operations Key Responsibilities (include but are not limited to) To provide QA oversight and approval of deviation, OOS, and change control records that have moderate to significant levels of complexity and/or novelty. Ensure records are properly initiated, investigated and resolved in accordance with established timelines. To provide QA oversight and approval of CAPA and EV records that have moderate to significant levels of complexity and/or novelty. Ensure CAPAs are initiated and resolved in a timely manner. Ensure escalation of deviations per procedures Identify efficiencies in the execution of the Deviation ad CAPA processes at TCF03 in a compliant manner Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues. Additional duties as assigned. These duties can be delegated to designated deputies of a satisfactory qualification level as needed. Basic Qualifications Masters Degree and OR Bachelors Degree and 2+ years experience in the biological sciences or related field OR AA Degree and 4+ years experience in the biological sciences or related field OR High School Degree and 5+ years experience in the biological sciences or related field Preferred Qualifications Quality Control background in Analytical, Virological, and Microbiological testing Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards Ability to effectively negotiate and build collaboration amongst individuals Proficient in MS Word, Excel, Power Point and other applications. Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities Pay Range 35-42/hr Based on experience #J-18808-Ljbffr Planet Pharma