QA Validation Specialist

Company Description

Axolabs is a business unit of LGC, and a leading provider of CRO / CDMO capability to the therapeutic oligonucleotide discovery and development industry. Centred out of LGC’s site in Kulmbach, Germany, Axolabs works closely with its customers to assist the identification and development of lead candidates with a broad suite of bioinformatics, biology, chemistry, manufacturing and analytical services that support discovery, pre-clinical and clinical trials and scale-up manufacture. With a track record in Nucleic Acid Therapeutics that traces back more than 20 years, Axolabs provides deep knowledge and expertise in the services it provides, working collaboratively and responsively with its clients to assist them in achieving their objectives.

Axolabs facility in Petaluma is focused on manufacturing scale-up and production to cGMP of multigram to kilograms of API for pre-clinical and clinical development. Our site in California has been involved in oligonucleotide synthesis for three decades and established the therapeutics activity in 2019. With around 70 staff and two manufacturing trains, Axolabs offers a flexible manufacturing service out of Petaluma that draws where necessary on our industry and chemical and analytical expertise in Kulmbach.

Job Description

· Support IQ/OQ and/or PQ activities, re-qualification, enrollment or commissioning for facility, HVAC systems, ISO clean rooms, utilities and equipment for GMP manufacturing operation.

· Responsible for creating, updating and maintaining associated documentations and reports relevant to project.

· Author, execute and/or review validation documents such as change controls, validation project plans, validation protocols, validation reports, risk management tools, gap analysis, CAPA, and validation exceptions/deviations

· Schedule and execute validations per standard operating procedures (SOP) and regulatory guidelines

· Participate in validation related investigations

· Champion and lead continuous improvement efforts on every aspect of validation

· Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions

· Foster cross-departmental relationships (QC, materials management, manufacturing, QA and site leadership) by representing validation at team meetings

· Employ good document practices (GDP) when recording data, maintaining archives, and drafting or reviewing documents

· Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q9, Q10 and applicable regulations and industry standard procedures

Qualifications

· At least 5 years of directly relevant work experience in cGMP validation of facility, equipment utilities in, pharmaceutical or biotech industry

· Bachelor’s in engineering, science, or equivalent working experience

· Ability to work independently or with minimal managerial oversight

· Must have working knowledge of cGMPs, International Society for Pharmaceutical Engineering (ISPE) guidelines, data integrity, 21 Code of Federal Regulations (CFR) Part 11 and Annex 11 regulations (electronic records and electronic signatures), industry good practices for Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ) and SOPs

· Requires strong interpersonal, verbal communication, and technical writing skills

· Working knowledge of industry regulations, standards and baselines from ICH, FDA, EU-GMP and WHO regulations etc

· Proven knowledge in the development and verification of commissioning and qualification equipment plans such as URS, FS, FAT, SAT, DQ, IQ, OQ, PQ, etc.

· Ability to manage priorities, deliverables, and schedule milestones

Additional Information

What we offer (US based-employees):

• Competitive compensation with strong bonus program
• Comprehensive medical, dental, and vision benefits for employees and dependents
• FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
• Deductible Buffer Insurance and Critical Illness Insurance
• 401(k) retirement plan with matching employer contribution
• Company-paid short- and long- term disability, life insurance, and employee assistance program
• Flexible work options
• Pet Insurance for our furry friends
• Enhanced Parental leave of 8 additional weeks
• PTO that begins immediately
• Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Company wide social events, frequent catered lunches and much more!

The typical pay