JT937 - SPECIALIST MANUFACTURING
About The Position
Quality Consulting Group is seeking a highly motivated Specialist Manufacturing to support pharmaceutical, biotech, medical device, and manufacturing operations in Puerto Rico and the USA. The role provides manufacturing and quality systems support, including process troubleshooting, change control, deviation investigations, validation, procedure management, training, and new product introductions. The specialist may own production processes and manufacturing documents, support commercial campaigns and floor operations, and assess opportunities for process improvement and equipment or automation changes. The position is identified as a non-standard shift.
Requirements
- Bachelor’s degree in Life Sciences, Biology, Chemistry, and/or Engineering.
- Experience providing on-floor manufacturing support and assessing process performance through operational observations and performance data analysis.
- Experience initiating, revising, reviewing, and approving manufacturing procedures.
- Knowledge of manufacturing process troubleshooting and issue resolution.
- Experience participating in New Product Introduction activities, including documentation, material, and training assessments.
- Familiarity with Change Control processes and preparation or review of CCRB packages.
- Experience supporting special projects, process improvements, and manufacturing initiatives.
Responsibilities
- Support execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions.
- Apply process, operational, and scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
- Serve as primary production process owner for process support systems when applicable and assist with ownership of more complex process systems.
- Own change controls for manufacturing process changes.
- Support major and trend deviation investigations through the full lifecycle, including root cause analysis, corrective and preventive action determination, authoring investigation reports, and presenting during regulatory inspections.
- Support risk assessment exercises and microbial assessment evaluations.
- Lead commercial campaign readiness and communicate and collaborate across functional areas.
- Assist in generating training materials and provide training on scientific or technical aspects of the process.
- Provide commercial support when needed and assist with troubleshooting on the manufacturing floor.
- Design, coordinate, and support functional tests, water tests, and other runs to challenge processes and operations during major changes or campaign readiness; generate technical protocols as needed.
- Assist with and provide guidance during Master Batch Record creation and revisions.
- Assess process, automation, or equipment modifications and implementation of special projects.
- Initiate, revise, and approve standard manufacturing procedures; ensure procedures reflect current operations and serve as a document owner.
- Assess process performance and review performance data; evaluate, plan, and implement process improvement solutions.
- Complete assessments for CAPA applicability requests from other plants or sites.
- Complete assessments for new or changed Bills of Materials.
- Serve as a peer-recognized specialist in at least one area and determine methodologies in that area.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
