M
Role & Company Overview
Employer
Medix™
Location / Model
Gibsonia, PA
Employment
Full-Time
Recruitment Type
Direct to HR Pipeline
Industry
General
Company Size
Headquarters
United States
Visa & Sponsorship
Global Talent Consideration
📋 Role Overview & Responsibilities
- Spreadsheet Verification: Set a schedule for regular verification, perhaps weekly or monthly, depending on the volume of data.
- Use automated validation tools where possible to streamline the process.
- Data Binder Review/Release: Establish a clear process for reviewing and releasing data binders, ensuring that all necessary documentation is complete and accurate before approval.
- Review/Approval of Study Protocols: Prioritize reviews based on project timelines and ensure thorough understanding of protocols to provide timely feedback.
- Review/Approval of Interim & Final Reports: Allocate time for thorough review of reports, balancing attention to detail with meeting deadlines.
- Review/Approval of Test Methods: Stay updated on industry standards and regulatory requirements to efficiently review and approve test methods.
- Review/Approval of Certificates of Analysis (CoA): Implement a streamlined process for reviewing and approving CoAs, verifying accuracy and compliance with specifications.
- Review/Approval of OOS/OOT (Out of Specification/Out of Trend): Act promptly to investigate and resolve OOS/OOT results, ensuring compliance with regulatory requirements.
- Review/Approval of Deviations: Establish a protocol for documenting and reviewing deviations, ensuring thorough investigation and appropriate corrective actions.
- Review/Approval of CAPA (Corrective and Preventive Actions): Prioritize CAPA actions based on risk and impact, ensuring timely implementation and effectiveness.
- Author New or Revised SOPs: Dedicate time for drafting and reviewing SOPs, involving relevant stakeholders for input and approval.
- Monthly Audit of Instrument Logbooks: Schedule regular audits and allocate time each month to review instrument logbooks for completeness and compliance.
- Participate in Sponsor Kick-off Meetings, Teleconferences, and Visits: Prioritize participation in these meetings, preparing in advance to contribute effectively to discussions and decision-making.
- Participate in Regulatory Audits: Prepare thoroughly for regulatory audits, ensuring all documentation is in order and actively participating in audit activities.
- Assist Quality Manager in Responding to Audit Reports: Collaborate with the Quality Manager to address audit findings promptly and comprehensively, implementing necessary corrective actions.
- Conduct Internal Audits: Follow the internal audit schedule, conducting audits with attention to detail and impartiality, and documenting findings appropriately.
- Follow cGMP Guidelines and Regulatory Requirements: Stay updated on cGMP guidelines and regulatory changes, ensuring all activities comply with applicable regulations.
Frequently Asked Questions
How do I apply for the Quality Specialist - 226139 position at Medix™? ▼
Click the “Apply for this Position” button on this page to submit your application directly to Medix™ without recruitment intermediary fees.
Is this position eligible for remote work or visa sponsorship? ▼
This position is located in Gibsonia, PA with potential relocation and sponsorship assistance depending on candidate qualifications.
Are there any candidate fees on Hirely? ▼
No. Hirely is completely free for candidates. We never charge registration fees or placement fees.
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