What are the responsibilities and job description for the Quality Assurance Specialist position at Bayside Solutions?
Quality Assurance Specialist
W2 Contract
Pay Rate: $30 - $40 per hour
Location: Salt Lake City, UT - Onsite Role
Job Summary:
The Quality Assurance Specialist will play a role in supporting GMP operations and ensuring the highest quality standards are being met in all areas across the facility, with a heavy focus on the floor support for manufacturing operations.
Duties and Responsibilities:
- Execute QA on the Floor program - 50% of the time
- Conduct manufacturing and warehouse walkthroughs
- Provide quality support to manufacturing operations
- Review batch records, test data, and logs
- Disposition materials
- Provide quality review for deviations, change controls, CAPA's
- Escalate quality issues
- Work with manufacturing on the floor proactively and in collaboration
Requirements and Qualifications:
- BS in a core scientific discipline
- 4 years of experience in Biotech Manufacturing / Quality Assurance / MSAT
- Familiarity with large molecule drug substance manufacturing
- Knowledge of current USP/Ph. Eur./FDA/ISO/GMP standards and guidance
- Previously experienced working in a GMP-regulated facility
- Well-developed verbal and written communication skills
- Ability to closely follow quality standards and pay attention to detail
- Strong collaboration skills
- Excellence in execution through accuracy, right first time, and a proactive nature
- Familiar with Master Control, Electronic Batch Records
Desired Skills and Experience
Quality Assurance, GMP, QA on the Floor, Manufacturing Quality Support, Biotech Manufacturing, Large Molecule Drug Substance Manufacturing, Batch Record Review, Electronic Batch Records, Test Data Review, Log Review, Material Disposition, Deviation Review, Change Control, CAPA, Quality Issue Escalation, Manufacturing Walkthroughs, Warehouse Walkthroughs, USP Standards, Ph. Eur. Standards, FDA Regulations, ISO Standards, GMP-Regulated Facility, MasterControl, MSAT, Quality Standards, Attention to Detail, Written Communication, Verbal Communication, Cross-Functional Collaboration, Right First Time, Proactive Execution, Scientific Discipline, Biopharmaceutical Manufacturing
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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Salary : $30 - $40