Analyst I, QC Raw Materials
QC Analyst I/II, Raw Materials 1338933
Location: Cambridge, MA (Onsite)
Science: Microbiome
Therapeutic Area: Infectious Disease, Inflammatory Disease, Oncology
Job Overview: You will be responsible for performing inspection, sampling, testing and labeling of raw materials according to established procedures and specifications. The role requires a good understanding of compendial requirements (USP, EP, JP, JPE, ACS, NF) as they relate to Raw Material testing. This position also includes responsibility of raw material specifications.
Responsibilities:
- Perform inspection, sampling, testing, labeling and release of raw materials and SU components for cGMP manufacturing use.
- Review raw data and results from contract laboratories for raw materials testing
- Initiate, review and manage to completion deviations, CAPAs and Change Controls.?
- Troubleshooting of inspection and sampling atypical results and perform OOS investigations as required.
Qualifications:
- BA/BS in the life sciences and 1+ years of GMP experience within Raw Materials and/or Quality Control or Quality Assurance
- Knowledge of USP, EP, and JP monographs
- Knowledge of method qualification for compendial materials
- Knowledge of cGMP/ICH/FDA/EU regulations
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.
PROVEN SCIENTIFIC PLACEMENT™
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.
Code: TechOps
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.