Drug Device Combination CMC Support
Drug Device Combination CMC Support 1347227
Location: Boston, MA (Onsite)
Science: Small Molecule
Therapeutic Area: Rare Diseases
Job Overview: The incumbent will be responsible for supporting CMC QA activities. A background in medical devices with quality engineering experience would be best suited for this role.
Responsibilities:
- Assists in CMC QA activities to support clinical development, submission, and approval of drug-device combination product.
- Support device design control activities and documentation reviews
- Preparation of Device History File.
- Preparation of Human Factor Risk Analysis
- Performs Archival of QA Records in EDMS (e.g., CMO batch records, data packages)
- Conduct follow up on Action Items for Quality Leadership Team (QLT) meetings
Qualifications:
- Bachelor’s degree and 0 – 3 years of relevant work experience in the Biotech or Pharmaceutical industry, or relevant comparable background.
- Good Understanding of 21 CFR part 820 and ISO-13485 regulations, guidelines, procedures, and policies relating to development, registration and manufacturing of drug-device to expedite the submission, review and approval of global CMC applications.
- Adaptability/flexibility
- Strong written and verbal communication skills
- Attention to detail
- Organizational/planning and coordination skills
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.