Quality Assurance Specialist
Quality Assurance Specialist
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Job Description
The Quality Assurance Specialist is responsible and accountable for quality tasks and operations. Possesses and applies a broad knowledge of Quality principles practices and procedures. Supports change control process CAPA system deviation process nonconforming material process customer complaints supplier approval material receiving internal audit process ad document control. Requires experience in ISO9001/ISO 13485 or cGMP manufacturing environment plus demonstrated familiarity with standard quality concepts.
2.0 Supervisory Responsibilities:
None.
3.0 Position Requirements:
Note: Qualifications are based upon education resume and/or work experience.
3.1 Minimum of 3 years of experience.
3.2 Possess a great attention to detail.
3.3 Must be able to work independently with minimal direction or oversight.
3.4 Must be able to maintain accurate and organized records.
3.5 Windowsbased computer skills familiarity with Microsoft Word and Excel.
3.6 Good organizational skills with ability to manage multiple priorities.
4.0 Responsibilities include (but are not limited to):
4.1 Must be able to take a leadership role in Quality related decisions.
4.2 Proactively ensure batch records are reviewed prior to material release ensuring paperwork is completed accurately neatly and fully.
4.3 Performs through root cause analysis and establishes indepth and robust corrective and preventative actions for both internal nonconformances and customer complaints.
4.4 Assesses materials received against internal procedures and performs the necessary approval to release materials.
4.5 Ability to read unplanned deviations change controls validations and other technical documents/reports to identify errors and/or potential noncompliance issues and to assess potential product/process risk.
4.6 Complete supplier approval paperwork for new incoming suppliers
4.7 Participate in internal audits and inspections including planning for audits and followup on audit findings.
4.8 Assists in the tracking and maintenance of document control activities.
4.9 Write revise and review standard operating procedures (SOPs) and custom specifications.
4.10 Become thoroughly knowledgeable of the applicable SOPs and maintain that knowledge base.
4.11 Other duties as assigned
5.0 Education:
5.1 4 year college degree in quality/compliance related field or sciencerelated field with 24 years related experience.
6.0 Physical Requirements:
6.1 Prolonged periods of sitting at a desk and working on a computer.
6.2 Must be able to lift up to 25 pounds at a time.
6.3 Must be able to access and navigate each department at the organizations facilities.
7.0 Working Conditions:
7.1 Conditions inside the office is generally quiet periodically there may be midlevel noise from various equipment when traveling to other facilities.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
