Company Description Axolabs specialises in a new class of drugs whose active ingredients are chemically derived from DNA or RNA. They are called oligonucleotide or nucleic acid therapeutics. We use our many years of expertise to help our clients make them a success. Some of these drugs have already been approved and are being used successfully against diseases that were previously untreatable in some cases. New drugs from this class are added every year. We believe in Science for a Safer World and are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organization. LGC Axolabs is located in Petaluma, US, Kulmbach and Berlin, Germany. Job Description Position Summary Join us at LGC as a Quality Assurance Specialist III - Therapeutics and be a part of our innovative team! In this role, you will support the Quality Assurance function at our brand new therapeutic GMP oligonucleotide facility. You will collaborate with various GMP functions to refine, develop, and improve our Quality Management System processes. Additionally, you will analyze process data, prepare trend analyses to drive continuous improvement initiatives, and implement procedures that adhere to both in-house and regulatory requirements. This is an outstanding opportunity to contribute to a company that is committed to excellence and innovation in the life sciences sector. Roles and Responsibilities: + Quality & Compliance: Complete all activities adhering strictly to quality and regulatory standards and procedures. Foster a focus on quality and strive for excellence in every task. + Continuous Improvement: Cultivate a culture of continuous improvement by demonstrating industrial excellence methodologies, lean metrics, and important performance indicators. + Accountability: Support employees and departments by communicating clearly and taking action. Ensure proactive communication with customers for timely issue resolution and partner concern. Facilitate cross-functional communication effectively. + Environment Health & Safety: Ensure compliance with LGC's safety and environmental guidelines. + Quality Systems: Coordinate key quality processes including Change Control, Audits, CAPAs, QA holds, Material Rejection Reports, Deviations, QMS, Technical Complaints, and QA reporting. + Quality Operations: Maintain GMP compliance and inspection readiness across the organization. + Investigations: Conduct and review investigations related to Complaints, Deviations, CAPA, OOS, Out of Tolerance, Atypical Results, Environmental Discrepancy Reports, and Alert Level Reports. + Batch Review: Perform meticulous technical reviews of manufacturing batch records and analytical testing records to ensure completeness and compliance with cGMPs, regulatory requirements, and internal procedures. + Material Controls: Manage the release of incoming and final products, including chain of custody, retain and sample shipment. + Customer Support: Offer technical and quality operations support with a focus on deviation training, coaching, and mentoring as needed. + Other Duties: Fulfill additional duties as required by site priorities and quality, business, or safety needs. Qualifications Minimum Qualifications: + A 4-year college degree in Engineering, Chemistry, Biochemistry, Biological Sciences, or a related field, or an equivalent combination of education, training, and industry experience. + Need 5+ years in Manufacturing, Quality Control, or Quality Assurance in pharmaceutical settings. + Proficiency in MS Office software applications (Word, Excel, PowerPoint, Outlook). + Strong technical writing and interpersonal skills. Preferred Qualifications: + Experience in CAPA, Deviation and Nonconformance reporting, internal auditing, and supplier management. + Extensive knowledge of ICH, FDA/EMA regulations for Active Pharmaceutical Ingredients and/or Finished pharmaceuticals. + Lead auditor training and/or certification. Proficiencies & Behaviours: + Outstanding interpersonal and communication skills. + Resonates with and operates in line with LGC's core values: Passion, Curiosity, Integrity, Brilliance, and Respect. + Promotes teamwork and dedication to achieving goals and deliverables. Physical Requirements: + Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Additional Information The typical pay range for this role is: Minimum: $ 73,891 USD Maximum: $ 120,764 USD This range represents the low and high end of the anticipated salary range for the California-based position. The actual base salary will depend on several factors such as experience, skills, and location. About LGC LGC is a top life science tools company, offering important components for key industries. Our Values: + PASSION + CURIOSITY + INTEGRITY + BRILLIANCE + RESPECT Equal opportunities: LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or birthing parent, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership. For more information about LGC, please visit our website www.lgcgroup.com #scienceforasaferworld