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Job Description
- Req#: 24-05348
Hourly Pay: ***
Shift Schedule: Saturday, Sunday, & Monday
Shift Time: 6:00 pm to 6:30 am
Quality Assurance Specialist
Job Responsibilities
• Reads, understands, and follows SOP’s and complies with cGMP’s
• Writes new standard operating procedures or revises existing documentation utilizing document management systems.
• Supports the evaluation and disposition of labelling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents.
• Supports the issuance and reconciliation of GMP documentation
• Electronic system usage with tools such as Trackwise, GQCLIMS, Client-X, FileTrail and SAP.
• Understands basic scientific principles and cGMP.
• Basic knowledge of functional procedures and routine activities within core area.
• Applies knowledge to recurring, standardized tasks.
• Uses basic analytical skills to develop solutions to task-related problems.
• Escalates/seeks support for more complex problems as appropriate.
• Works under regular and routine supervision following standard procedures.
• Receives detailed instructions for new assignments.
• Priorities are set by others.
• Work is reviewed for accuracy and completeness.
• Contributes to department goals through quality and efficiency of standard work.
• Contacts are primarily with department peers and supervisor and cross-functionally with peers/supervisors from other internal departments. Rarely any external contacts.
Experience
• Minimum of 2 to 3 years of biopharmaceutical/pharmaceutical experience
• Minimum of 1 year of QA/QC or validation experience
Education
• Bachelor's in biology, engineering or related field is required
Knowledge
• Understanding of basic scientific principles. Understanding of basic biotech manufacturing processes. Good understanding of cGMPs, Regulatory standards and concepts.
Problem Solving
• Develops solutions to a variety of compliance problems of moderate scope and complexity.
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”About the company
Mindlance is one of the largest diversity-owned staffing firms in the US . As a recruitment centric talent acquisition company, Mindlance provides Technology, Engineering, Digital / Creative / Marketing, Clinical Research, Scientific, Finance, Professional and Payroll Management staffing services to Global 1000 companies across the US, Canada and India.
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