...procedures, testing (methods) in manufacturing, documents and records, batch record review, MES, EBR, SAP, Trackwise; including but not limited... ...experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development
• Experience with Validation...
...sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own... ...approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and...
...sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own... ...approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and...
...process
• Perform oversight of the process and procedures/GMP tasks
• Manage Change Controls and deviations for review and approval as QA contact
• Work with operations to resolve basic compliance discrepancies
• Knowledge in Validations and Laboratory area and...
...fields.
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Job Description
Specialist QA with experience in:
Aseptic Technics
Change Control
New Product Introduction
Qualifications
Doctorate degree...
...under the highest ethics standards for the following position:
~Specialist QA
Description:
Perform one or more of the following duties... ...approve EMS/BMS alarms.
~Approve NC investigations and CAPA records.
~Approve change controls.
~Provide lot disposition and authorize...
...• Perform oversight of the process and procedures/GMP tasks
• Manage Change Controls and deviations for review and approval as QA contact
• Work with operations to resolve basic compliance discrepancies
• Knowledge in Validations and Laboratory area and equipment...
.... Respond to inspector questions as necessary. Support regulatory inspections by directly interfacing with inspectors to review batch records, process validation, non-conformances, etc.
May present process overviews to inspectors and accompany inspectors on tours of process...
Minimum Requirements
Mid-level individual contributor on a project or work team, 3-5 years of experience required.
Bachelor Degree in Engineering
Experience within Medical Devices and/or Pharmaceutical industries.
Experience in equipment IQ, OQ and PQ, Validation...
...have established a Quality Management System which provides a framework for measuring and improving our performance. Compliance Specialist 2018 2 Job Description GIDEP).
Act as a point of contact for customers, suppliers, and internal employees with regard to all contracts...
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world...
For Quality services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's Degree with five (5) years of Manufacturing Operations experience within the pharmaceutical or regulated industry.
Bilingual (English & Spanish).
Project...
...under the highest ethics standards for the following position:
~Specialist Quality Complaints
Primary responsibilities include:... ...Device Manufacturing processes)
~Ensures quality of complaint records, consolidated / trend investigations
~Facilitate cross-functional...
Qualified candidates must have the following expertise;
Experience in manufacturing/packaging deviations, Root Cause Analysis, complaint investigations, project management and compliance.
Requirements
Qualified candidates must comply with years of experience...
...are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
~Specialist Quality Complaints
Primary responsibilities include: Supporting the product complaint system through; leading and managing product...
For Automation and Troubleshooting services in the Engineering and Packaging area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor Degree with two (2) years or Associate Degree with six (6) years of exposure supporting Engineering department and activities...
...the highest ethics standards for the following position:
~Sr Specialist Tech Engineering
FUNCTIONS:
~Evaluate and optimize Preventive... ...any pest control issues.
~Support the documentation and records related to the pest control program.
~Deviations and CAPAs:...
...fields. 8. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining... ...systems (SCADA). 17. Familiarity with industry standards for batch control systems, software development life cycle methodologies,...
...discipline expertise to broad variety of assignments in related fields.
6. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
7. Application of mature engineering...
...of discipline expertise to broad variety of assignments in related fields.
Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Application of mature engineering...
...of discipline expertise to broad variety of assignments in related fields.6. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.7. Application of mature engineering...
...engineering approaches, design concepts and specification requirements to best utilize equipment and manufacturing techniques.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/...
...of discipline expertise to broad variety of assignments in related fields.
#Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
#Application of mature engineering...
...of discipline expertise to broad variety of assignments in related fields.
Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Application of mature engineering...
...discipline expertise to broad variety of assignments in related fields.
6. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
7. Application of mature engineering...
...of discipline expertise to broad variety of assignments in related fields.
Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Application of mature engineering...
...of discipline expertise to broad variety of assignments in related fields.
~Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
~Application of mature engineering...
...of discipline expertise to broad variety of assignments in related fields.
Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Application of mature engineering...
...projects. Plans and coordinates larger-scale engineering projects or several medium or small projects while acting as a technical specialist for a specific section. Maintains a thorough knowledge of new developments and technology. Monitors projects and recommends...
...Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or...