Stability Associate Pharmaceutical Development Jobs Vacancy in Alexion Pharmaceuticals Inc New Haven
Alexion Pharmaceuticals Inc New Haven urgently required following position for Stability Associate Pharmaceutical Development. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.
Stability Associate Pharmaceutical Development Jobs Vacancy in Alexion Pharmaceuticals Inc New Haven Jobs Details:
- Serve as contact person for external vendor management of clinical sample management at CMO including retention program.
- Facilitate inventory and annual inspection of clinical retention per procedures and regulatory guidance’s at external vendor.
- Generate, review and approve CMO protocols for stability and retention storage.
- Perform data audit and verification for release and stability testing performed by CROs.
- Track and trend stability data from CMO portals.
- Maintain and communicate stability pull calendars and shipments.
- Generate stability Test Result Forms and facilitate sample submission to test laboratories.
- Generate and maintain stability data tables for multiple products; perform data entry and verification.
- Manage stability studies and data in LIMs.
- Generate and maintain JMP tables as required.
- Generate product specific stability update reports, stability study final reports and route for review and approval.
- Write and revise stability protocols, SOPs and PRCs as required, route for review and approval.
- Follow written procedures (PRCs) and stability protocols (QUAs) as well as GMP guidance documents.
- Prepare, review and file testing and supporting documentation; perform other clerical functions as assigned.
- Generate Certificates of Testing
- Perform all job functions in compliance with cGMPs and maintain accurate and legible records.
- Provide stability assessments in support of laboratory investigations, contractor deviations and storage deviations.
- Ensure training is current for all job functions performed. Attend all required Company training.
- Assist in other Ph. Dev. Stability tasks as trained and assigned.
- Assure quality documents are scanned and archived according to procedures.
- May include travel, up to 10%
- A successful candidate will typically have 5-8 years' of experience working in a relevant laboratory setting
- Knowledge of GMPs and their application in the environment is preferred.
- Have a strong working knowledge of governing documents for stability and clinical retention programs.
- Able to understand and follow written procedures.
- The ability to communicate verbally and in a written format is required, able to work cross functionally and act as liaison for vendor contracts.
- Document stability results with a strong attention to detail; able to recognize trends outside of expected results.
- Able to organize his/her own work on a routine basis and requires minimal supervision. When asked, the individual is able to provide updates and tracking on his/her tasks.
- Ability to interact with Analytical Sciences Operations groups, Quality Assurance and GPD members.
- Able to navigate external vendor sites and portals for data extraction and review.
- Able to communicate findings to colleagues within the group through presentations.
- Proficient with various MS Office programs, including Word, Excel, Outlook, and PowerPoint as well as SAS JMP statistical software.
- Previous experience with Laboratory Management Systems (LIMs)
- A successful candidate will typically hold a BS degree in Biochemistry, Chemistry, Chemical Engineering or related discipline from an accredited university with 5- 8 years’ of relevant experience or equivalent combination of education and experience.
- Problem solving skills: Solves routine technical and logistical problems
- Scientific Inquisitiveness: Understands background of assigned technical tasks to be resourceful to management and others
- Communication skills: Discusses work with supervisor and coworkers; Drafts, edits and finalizes technical documents with templates under supervision
- Technical expertise: Working knowledge of Excel and SAS JMP or other statistical software
- Strategic ability: Understands priority of assigned tasks with limited supervision
- Ownership: Works with supervisor and coworkers to ensure assigned tasks are completed
- Accountability: Consistent focus on quality and compliance
- Collaborative Innovation: Experience with stability LIMS