- Provide Quality review for external production and testing activities for clinical trial material
- Review and assess deviations, including risk assessments, participate in root cause analysis investigations, tracking and follow up
- Review and approval of analytical testing protocols, methods and validation report
- Work cross functionally to ensure all regulatory requirements are met with regards to the production and testing clinical trial materials as well as the oversight of third parties
- Participate in Site Visits and/or Quality audits for CMOs and CTLs as needed
- Review of Qualification activities for CMOs and CTLs
- Ensure Quality Agreements are followed for contracted activities
- Coordinate disposition activities for investigational products
- Conduct QA review of GMP documents
- Support review of regulatory filing activities as needed
- Establish and maintain internal procedures in compliance with FDA, ICH, EU, and other country-specific regulations
- Participate in Health Authority inspections
- Represent Quality at internal and external project team meetings as needed
- Communicate with CMOs and Contract Laboratories, as appropriate
- Additional Quality Assurance activities as required
- Bachelor's in Science, Engineering or a related discipline preferred
- Minimum of 3 years of relevant work experience in a pharmaceutical/biotech environment
- GMP quality assurance experience in the pharmaceutical or biotechnology industry
- Understanding of GMP regulatory requirements and implementation (FDA, ICH, EMA, etc.
- Technical writing or investigation writing experience
- Strong aptitude with Microsoft Office applications (Word, Excel and Teams) and Adobe.
- Experience with Veeva preferred
- Strong interpersonal and communication skills (written and verbal), team player, and flexible without compromising quality
- Strong organizational skills
- Ability to work independently and follow up on pending actions without being prompted
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Senior Specialist, Quality Assurance - Boston, United States - PepGen
Description
Sr Specialist, Quality AssurancePosition Summary
The Sr Specialist Quality Assurance will be responsible for quality review of production and testing of clinical trial materials at external manufacturing site. Routine activities including review and approval of master batch records, executed batch records, analytical testing protocols, methods, reports and testing records. The Sr Specialist will coordinate disposition activities. The position calls for excellent written and verbal communication skills with internal and external customers, peers, and managers. The Sr Specialist ensures continued compliance with FDA and other applicable regulations.
Responsibilities
PepGen Inc. is a clinical-stage biotechnology companyadvancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen's Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases. For more information, or follow PepGen onTwitterandLinkedIn.
EEO Statement
PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
Recruitment & Staffing Agencies
PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all our recruiting needs. Thank you.
