Plant Technician Quality Assurance Specialist Job Summary:
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We are seeking an experienced Quality Assurance (QA) Professional to join our team as a Plant Technician QA Specialist. This senior role is ideal for someone with a strong technical foundation in aseptic process validation, technology transfer, and new product introduction.
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Key Responsibilities:
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* Act as the Quality point of contact and decision-maker during New Product Introductions, Technology Transfers, and Process Validation activities for aseptic products, ensuring full compliance with regulatory expectations.
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* Review and approve Process Development and Validation documentation, including technical transfer documents, validation protocols, and executed reports.
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* Provide Quality direction and input at Change Control and Deviation Review Boards, maintaining QA oversight of all change control and Deviation/CAPA records.
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* Ensure all records are clearly scoped, with timely and robust implementation of activities.
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* Perform all responsibilities in strict compliance with our safety standards, procedures, and SOPs.
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Required Skills and Qualifications:
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* 7+ years of experience in a QA or validation-focused role within the pharmaceutical or biotechnology sector.
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* A degree in Science or Engineering is preferred.
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* Deep understanding of Validation, NPI, and aseptic manufacturing.
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* Proven ability to lead within Deviation/CAPA/Change Control processes.
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* Strong critical thinking and cross-functional communication skills.
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* Comfortable working independently and remotely.
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* A team-oriented mindset, with confidence to challenge and collaborate.
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Benefits:
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This position offers a challenging and rewarding career opportunity with opportunities for growth and development. If you are a motivated and detail-oriented professional looking for a new challenge, please apply today!