Job Listing
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| Job ID: 14036974 |
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| Job Location: |
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| How to Apply: | To see employer contact information, log in or register. |
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| Job Title: | Quality Assurance Specialist |
| Work Type: | Work Days: Weekdays, Work Vary: No , Shift: First (Day), Hours Per Week: 40, Work Type: Regular |
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| Salary Offered: | Unspecified |
| Benefits: | 401(k) or other retirement, Dental Insurance, Health Insurance, Vacation or PTO, Vision Plan |
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| Physical Required: | Unspecified |
| Drug Testing Required: | Unspecified |
| Education Required: | |
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| Experience Required: | Unspecified |
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| Required Skills: | Bachelor’s degree in Life Sciences or related field required.
· 5+ or more years of relevant experience required.
· 5+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry preferred. |
| Preferred Skills: | · Must have full understanding of pharmaceutical change control.
· Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes, and facility systems.
· Working knowledge of cGMP regulations and guidelines and their application in a controlled aseptic environment is strongly preferred.
· Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcomes.
· Ability to adapt quickly in a fast-paced dynamic environment.
· Ability to communicate with and positively influence broad and diverse populations within and outside the organization.
· Strong collaboration, including problem solving and continuous improvement efforts, and
communication with the Engineering, Operations, Research and Development teams.
· Working knowledge of Microsoft Office Suite specifically Microsoft Word and Excel
· strongly preferred.
· Working knowledge of Adobe editing software strongly preferred
· Working knowledge of working in hybrid QMS system (paper/electronic)
· Demonstrated ability to manage timelines and priorities.
· Demonstrated ability to work independently with minimum guidance.
· Demonstrated ability to multi-task and focus attention to detail.
· Knowledge of how and ability to write, review, and revise Standard Operating Procedure (SOPs). |
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| Job Description: |
Job Title: Quality Assurance (QA) Specialist
Reports to: Quality Management Systems (QMS) Manager
Classification: Full Time, Exempt
Work Location: Onsite - Rochester, MN
POSITION SUMMARY:
The Quality Assurance (QA) Specialist is responsible for implementing and supporting the Quality Management System (QMS) in accordance with company policies and procedures.
PRINCIPAL RESPONSIBILITIES:
· Write, revise, review, and approve site procedures and policies.
· Review and approve investigations and associated CAPAs, Change Controls and nonconformance.
· Participates in regulatory agency (i.e., FDA, etc.) inspections.
· Investigate or serve as GMP QA approver for customer complaints, deviations / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented.
· Assemble, analyze, and report QA data (metrics) to ensure regulatory compliance, identify trends and to identify areas of improvement.
· Review Batch Records and provide final product disposition.
· Conducts internal audits of GMP Quality Systems and sub systems.
· Aide in assessing risk during Supplier Qualifications or Material Assessments.
· Ensure that components, containers, closures, in-process materials, packaging materials,
labeling, and finished dosage forms are examined and approved or rejected to ensure that all
these meet their current specifications.
· Oversee the examination and evaluation of each lot of incoming material before use to ensure
that the material meets its established specifications by conducting incoming material disposition.
· Reviews and assesses in-house solution preparation and external material testing.
· Document Control, Training, Quality Systems back-up, and key trainer for conducting GMP training.
· May assist in conducting Supplier Qualification and reviews.
· Ensure manufacturing and analytical equipment is appropriately maintained and calibrated.
· Performs other duties as assigned
Refer to ID when applying |
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