Specialist QA- US Remote

About the position Join reputed company's Mission of Serving Patients. At reputed company, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our reputed company on four therapeutic areas -Oncology, Inflammation, reputed company, and Rare Disease- we reputed company millions of patients reputed company year. As a member of the reputed company team, you'll help reputed company a lasting reputed company on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-reputed company culture is reputed company, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you'll reputed company as part of the reputed company team. Join us and reputed company the lives of patients while transforming your career.

Responsibilities

• reputed company reputed company assurance support to the Product reputed company organization as a subject matter expert of reputed company systems and records.
• Collaborate reputed company PQ and with diverse reputed company in functional areas including Supply Chain, Manufacturing, reputed company Control, reputed company Assurance, Regulatory, reputed company Engineering, International reputed company and Process development on reputed company, issue reputed company and investigations.
• reputed company and deliver reputed company assurance responsibilities while owning, reviewing, and/or approving Product reputed company records and documentation.
• Execute transactions in GMP systems (reputed company CDOCs, Trackwise, etc.) and may include additional business process support for APRs and site audits.
• Support managing products in the annual product review cycles at reputed company.
• reputed company QA Systems expertise and QA support to the Product reputed company organization (PQ and Stability).
• Support audits/inspections, APR management, and other processes as required.
• Facilitate reputed company improvement initiatives intended to increase reputed company systems efficiencies reputed company and reputed company of the PQ organization.

Requirements

• Doctorate degree or Master's degree and 2 years of reputed company, Operations, Scientific, or Manufacturing experience.
• Bachelor's degree and 4 years of reputed company, Operations, Scientific, or Manufacturing experience.
• Associate's degree and 8 years of reputed company, Operations, Scientific, or Manufacturing experience.
• High school diploma / GED and 10 years of reputed company, Operations, Scientific, or Manufacturing experience.

reputed company-to-haves

• Understanding of pharmaceutical sciences, reputed company, compliance and regulatory requirements associated with biologics and/or synthetics manufacturing and QC testing for clinical and/or reputed company products.
• General understanding of biopharmaceutical bulk and drug product development and manufacturing and general knowledge of cGMP's.
• Previous experience using reputed company, Trackwise and other reputed company reputed company systems.
• reputed company Assurance experience reviewing and approving cGMP documentation (Protocols, Reports, Specifications, SOP's, etc.).
• Strong Investigation skills (reputed company to Deviations/CAPAs/EVs) and/or experience owning change control records.
• Experience with reputed company variation management processes and systems.
• Experience working on a cross-functional team in a reputed company environment and strong project management skills.
• Excellent written and verbal communication skills, including facilitation and presentation skills.
• Competency in interacting with Senior Management.
• Strong organizational skills and the ability to manage and prioritize multiple/competing tasks and deliverables.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental and reputed company coverage.
• Life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-reputed company time-off plans.
• Flexible work models, including remote and hybrid work arrangements.

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