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 | Location  | City | Job Type | Job Title | Category | Status |  |
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| CA | Thousand Oaks | Temporary | Scientific Project Manager | Scientific | Open | | | Utilizing clinical and scientific literature analysis skills, writes and updates medical information response documents, including letters and clinical FAQs, dossiers. Provides comprehensive literature review and data analysis to identify products. Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
Position Description
- Utilizing clinical and scientific literature analysis skills, writes and updates medical information response documents, including letters and clinical FAQs, dossiers.
- Provides comprehensive literature review and data analysis to identify products.
Position Requirements - Pharm.D., PhD., NSc., M.D., D.O.
- Scientific literature analysis experience
- Organizational and project management skills
- Technical writing experience
- Computer Skills: MS Word, Excel
Benefits - Blue Cross/Blue Shield Medical and Vision
- Delta Dental
- 401K with Company Match
- Holiday and Vacation Pay
- Relocation Assistance
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| | | IL | Melrose Park | Permanent | Scientific Project Manager | Scientific | Open | | | Delta Scientific is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.
Come be a part of our success story!
Job Title
- Quality Assurance Manager
Position Description
- This position will be responsible for establishing, implementing, and maintaining Quality Systems SOPs and Analytical Test Methods related to technical transfer activities associated with the manufacturing integration of over 100 SKUs. The candidate will be responsible for review and approval of analytical data, product technical transfer protocols, stability studies etc. and will manage analytical investigations (equipment, stability, out of specification (OOS).
Position Responsibilities
- This role will focus on technical and operational quality decisions associated with product transfer actives such as: leadership skills, self motivation, integrity, ethics and a solid commitment to drug safety.
- Approving and auditing test method transfers / verifications
- Approving and auditing stability data
- Approving and auditing technical transfer protocols and final reports
- Approving technical transfer related documentation (e.g., SOPs, Master Batch Records, and Investigation Reports etc.
- The position will be working directly with the technical transfer team and site staff to integrate the products on time and on budget.
Position Requirements - Review and approve analytical data package for API, finished drug products and stability
- Write, review, and approve SOPs, test methods, specifications, protocols, reports, and other documentation related to QC and analytical testing
- Perform a comprehensive review and assessment of stability data (e.g., OOS investigations)
- Prepare stability sections for regulatory/QC documents in support of PASs and CBEs
- Manage with site staff the qualification/validation of analytical methods, approval of validation protocols and reports, specifications, batch records and changes related to methods and specifications
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