Quality Assurance Specialist IV - Therapeutics

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 IV- 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: Execute all activities following quality and regulatory standards and procedures. Promote a quality mindset and quality excellence approach to all activities.
• Continuous Improvement: Support continuous improvement culture, industrial excellence methodologies, lean metrics, and key KPI’s.
• Accountability: Support employees and respective departments in a manner which is clear in approach, communication, and action. Provide proactive communication to customers to ensure timely escalation and resolution of issues. Follow up on issues to ensure completion in a timely manner. Support cross functional communication in all manners.
• Environment Health & Safety: Support adherence to application of LGC safety and environmental guidelines.
• Quality Systems: Independently handle  the following quality processes: Change Control, Internal and External Audits, CAPAs, QA holds, Material Rejection Reports, Deviations, QMS, Technical Complaints, QA reporting and approval of GMP documentation.
• Quality Operations: Supports GMP compliance and inspection readiness within organization.
• Investigations: Performance and review for investigations associated with Complaints, Deviations, CAPA, OOS, Out of Tolerance, Atypical Results, Environmental Discrepancy Reports and Alert Level Reports.
• Batch Review: Perform technical review of the manufacturing batch records and analytical testing records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures. Review batch records, summary reports and other release documentation as necessary.
• Qualification and Validation: Review and approve equipment/instrument/computerized systems qualification protocols and reports.
• Material Controls: Perform release of In-Coming and Final Product release including management of chain of custody, retain and sample shipment
• Customer Support: Provide technical and quality operations support to respective departments with a focus on deviation training and coaching/mentoring as needed.
• Other Duties as mandated by site priorities and Quality, Business, or Safety requirement.

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 7+ 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 Requireme