Senior Specialist, Quality Assurance - Boston, United States - OSI

Description

Sr Specialist, Quality AssurancePosition SummaryThe 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.
ResponsibilitiesProvide Quality review for external production and testing activities for clinical trial materialReview and assess deviations, including risk assessments, participate in root cause analysis investigations, tracking and follow upReview and approval of analytical testing protocols, methods and validation reportWork 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 partiesParticipate in Site Visits and/or Quality audits for CMOs and CTLs as neededReview of Qualification activities for CMOs and CTLsEnsure Quality Agreements are followed for contracted activitiesCoordinate disposition activities for investigational productsConduct QA review of GMP documentsSupport review of regulatory filing activities as neededEstablish and maintain internal procedures in compliance with FDA, ICH, EU, and other country-specific regulationsParticipate in Health Authority inspectionsRepresent Quality at internal and external project team meetings as neededCommunicate with CMOs and Contract Laboratories, as appropriateAdditional Quality Assurance activities as requiredRequirementsBachelors in Science, Engineering or a related discipline preferredMinimum of 3 years of relevant work experience in a pharmaceutical/biotech environmentGMP quality assurance experience in the pharmaceutical or biotechnology industryUnderstanding of GMP regulatory requirements and implementation (FDA, ICH, EMA, etc.
Technical writing or investigation writing experienceStrong aptitude with Microsoft Office applications (Word, Excel and Teams) and Adobe.

Experience with Veeva preferredStrong interpersonal and communication skills (written and verbal), team player, and flexible without compromising qualityStrong organizational skillsAbility to work independently and follow up on pending actions without being promptedAbout PepGenPepGen 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.

PepGens 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, visit or follow PepGen onTwitterandLinkedIn.
EEO StatementPepGen 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 AgenciesPepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all our recruiting needs. Thank you.#J-18808-Ljbffr