Job Overview
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Date PostedAugust 28, 2022
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Location (State / UT)
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Expiration date--
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Experience5 Years
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GenderAny
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Desired QualificationBachelor Degree, Master’s Degree
Job Description
- Contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects within a team.
- Lead efforts to improve process performance, procedures, and reporting to meet changing quality and regulatory compliance.
- Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.
- Perform tasks associated with maintaining Current Good Manufacturing Practices {part of GxP} compliant Quality Control and Stability laboratories.
- Support preparation of media, receipt, storage, and handling of Bio ball cultures, and investigations related to microbiology.
- Support detailing requirements for Laboratory Information Management System builds, building, testing, and managing its Master Data changes.
- Review and authorize all laboratory data and have extensive overall knowledge of all laboratory operations.
- Serve on cross-functional teams to represent Quality Control and facilitate communications and activities/projects
- Perform safety inspection of laboratories and surrounding office area as assigned and prepare a report.
- Participate in out-of-specification and failure investigations and recommend corrective actions and demonstrate problem-solving abilities.
- Train junior colleagues and may develop training plans and/or oversee training activities for groups.
Qualifications
Must-Have
- Bachelor’s Degree in Pharmacy or Masters in chemistry/ Pharmacy
- 5+ years experience in Analytical equipment calibrations and Qualifications
- Good knowledge of Change controls and investigations
- Understanding of pharmaceutical manufacturing, packaging, and quality assurance operations
- Detail-oriented with Quality systems knowledge
- Excellent effective written and verbal communication and interpersonal skills
- Ability to work in a team environment
Nice-to-Have
- Relevant pharmaceutical experience
- Knowledge of computer system hardware, infrastructure, and networks