Vacancy expired!
Company Description
Bio-Tech
Job Description
Job Details:
Will assist with document review and initiate incidents, as well as coordinate and compile general documents and oversee room clearance inspection.; Skills: ; quality assurance or manufacturing experience in the pharmaceutical or medical device industry
- Responsible for SM LIMS data coordination activities, including sample reconciliation and CoA generation.
- Responsible for management of SM LIMS approval based tasks; aligned to source documentation.
- Responsible for supporting validation activities for SM LIMS and associated quality document management.
- Responsible for data queries from QC’s electronic systems.
- Responsible for QC Assessor for Change Controls impacting analytical systems.
- Provides ownership and QA oversight for document management of various processes within QC.
- Comply with safety guidelines, cGMPs and other applicable regulatory requirements.
- Supports inspection readiness activities across Quality Control, and site audits and inspections.
- Maintains project plan commitments supporting critical projects
- Supports Continual Improvement initiatives, programs and projects.
Qualifications
Top 3 Must Have Skill Sets:
o Experience with SM LIMS (data reporting management system, laboratory information system)
o Experience with system validation, specifically SM LIMS (system validation)
o Quality Assurance oversight and record management, specifically deviations, corrective/preventive actions and effectiveness verifications (ownership of documentation, data entry verification)
Additional Information
Soft Skills
o Project management
o Proficiency in Excel, Word, and Power Point
o Strong interpersonal skills
Vacancy expired!