Senior Quality Assurance Specialist

Primary Responsibilities: Coordinate Global Incoming Quality Process Operations to support Global Process Owner lead. Interface with IQA Network, various company sites and business partners to ensure maintain process in compliance and alignment. Complete and approve multisite procedures, deviation, change control and other quality records to support RM Network. Candidate must have strong leadership skills, communication skills, and the ability to approach issues from a strategic perspective. This includes the ability to translate strategy into challenging, actionable objectives to effectively drive your team, advocate client positions throughout the life cycle of the project and make value-based decisions. Requirements: Bachelor's Degree in Life Sciences or related field or the equivalent combination of education and/or experience. Typically 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry. Evaluate documentation and operation and documentation according to company guidelines. Be self motivated, attentive to details and able to prioritize and meet deadlines. Basic statistical mathematical skills including the ability to trend data. Basic project management skills. Independently understand, follow and implement instructions. Strong word processing, database and spreadsheet application skills. Strong organizational skills with the ability to manage multiple projects or assignments. Top 3 Must Have Skill Sets: IS skills: Tableau; Smartsheet; Spotfire; Microsoft Project Management Application Able to extract and assess data from multiple systems (LIMS, SAP, LMES, QMTS) Strong leadership skills and PM experience Excellent conceptual problem-solving skills with demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution Must have change control, deviation, investigation process and technical writing experience Compensation: The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements). Benefits and Ancillaries: Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee. Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. AditiConsulting