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The Senior Quality Assurance Contract will provide a range of Quality Assurance functions related to various programs. This individual’s responsibilities will include review of executed batch records and processing of change controls, review of technical protocols and reports including analytical methods validations and method transfers, reference standards protocols and reports.
He / She will review regulatory dossier sections as well as verification and trending of process data and deviations.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES :
These may include but are not limited to :
Review executed Batch and Formulation Records
Develop and execute change control implementation plans
Verify and reference rHuPH20 Dossiers
Review and edit Standard Operating Procedures
Review technical and stability reports as well as protocols
Perform Quality Assurance activities associated with the maintenance of other internal Quality Systems such as : deviation trending and CAPA system
Perform Quality Assurance review and / or document audits
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES :
Other duties as assigned
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES :
A minimum of Bachelor’s degree with at least 7 years’ experience in Quality Assurance (an equivalent combination of experience and education may be considered)
Strong work experience in the pharmaceutical, device, diagnostic or medical field
Working knowledge of batch record review
Demonstrated attention to detail with an ability to detect and correct errors / inconsistencies in various types of documents
Advanced knowledge and understanding of GMPs
Exceptional ability to multi-task under tight deadlines
Excellent written and verbal communication skills as well as the ability to build key successful partnerships across the organization with both internal and external stakeholders
TECHNICAL KNOWLEDGE REQUIRED :
Equipment : PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained.
Knowledge of other equipment required : N / A
Software Knowledge : Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required : EDS, Veeva QualityDocs (preferred)
INTERNAL AND EXTERNAL RELATIONSHIPS :
Maintain productive relationship and open communication with Regulatory, Manufacturing, Product Development, Research and Development, Project Teams, and Clinical Research / Operations
Maintain productive and cooperative relationship with partners and contract manufacturing, test organizations, and other contract service providers as required
Interface with QC, Manufacturing, Supply Operations, Product Development, Regulatory Affairs, and other departments in support of company goals and initiatives
