Oq Jobs in Minnesota (NOW HIRING)

Prepare draft OQ/PQ plans and validation documentation . * Define mold validation scope and validation requirements. * Review mold trial results and recommend process changes when required.

OQ Protocols * PQ Protocols * IOQ Protocols * Validation Summary Reports * Qualification Traceability Matrices * Generate User Requirement Specifications (URS) when required. * Develop test scripts ...

OQ Protocols * PQ Protocols * IOQ Protocols * Validation Summary Reports * Qualification Traceability Matrices * Generate User Requirement Specifications (URS) when required. * Develop test scripts ...

Develop operational qualification (OQ) and performance qualification (PQ) protocols, execute OQ/PQ activities on products, and create comprehensive OQ/PQ reports. * Create and enter work instructions ...

Support process validation activities including IQ/OQ/PQ protocols and execution. * Collaborate with cross-functional teams including Quality, R&D, Regulatory Affairs, and Production. * Analyze ...

Process Qualifications (IQ/OQ/PQ) * Test Method Validations * Gage R&R and Process Capability Studies * Design of Experiments (DOE) and FMEAs * Support CAPA, NCR, and complaint investigations ...

Experience in Lean Manufacturing, Six Sigma, IQ/OQ/PQ and process validation. Experience in thermoplastics, polyolefins, polymers, HDPE, llDPE, LDPE, polyethylene, or polypropylene would be a plus.

Build and maintain engineering procedures supporting Design Controls, Process Characterization, IQ/OQ/PQ, TMV, and technology transfer activities. Develop engineering metrics that measure project ...

Build and maintain engineering procedures supporting Design Controls, Process Characterization, IQ/OQ/PQ, TMV, and technology transfer activities. * Develop engineering metrics that measure project ...

Perform Equipment Installation, Mfg Process Characterization, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) activities, as well as Software Validation and Test Method Validation ...

Build and maintain engineering procedures supporting Design Controls, Process Characterization, IQ/OQ/PQ, TMV, and technology transfer activities. * Develop engineering metrics that measure project ...

Supports and executes validation activities, including IQ, OQ, and PQ protocols and reports, as directed. * Carries out quality planning activities including Process Flow Diagrams, Process FMEAs, and ...

Develop, execute, and support process validation activities, including IQ, OQ, and PQ. * Conduct and support risk assessments and establish appropriate manufacturing process controls. * Identify and ...

Develop, execute, and support process validation activities, including IQ, OQ, and PQ. * Conduct and support risk assessments and establish appropriate manufacturing process controls. * Identify and ...

Support line validation and qualification activities including IQ, OQ, and PQ authoring protocols and reports and executing testing. Develop and document statistical rationale for sampling plans ...

Support line validation and qualification activities including IQ, OQ, and PQ -- authoring protocols and reports and executing testing. * Develop and document statistical rationale for sampling plans ...

Support IQ/OQ/PQ validation activities and review quality documentation * Maintain DHF documentation and support product lifecycle activities * Review batch records, work orders, and manufacturing ...

Demonstrated experience authoring and executing IQ/OQ/PQ protocols. * Strong knowledge of GMP regulations, FDA guidance, ASTM E2500, GAMP, and ISPE methodologies. * Experience managing deviations ...

Support process validation activities (IQ/OQ/PQ) * Drive continuous improvement initiatives (Lean, Six Sigma) * Ensure compliance with FDA, ISO 13485, and GMP requirements Required Qualifications

Plan, document and execute process development and process validations including IQ/OQ/PQ, drafting protocol/reports, risk management (PFMEA), and statistical data analysis. * Improve manufacturing ...