Specialist Manufacturing - 09

Flexible & Integrated Technical Services, LLC•Juncos, PR

2d•Onsite

About The Position

This role is for Manufacturing Services in the Quality Systems area. The ideal candidate will possess a Bachelor's Degree with five (5) years of experience as a Scientist within the pharmaceutical or regulated industry. Bilingual (English & Spanish) skills are required, along with Project Management experience. The shift is administrative and according to business needs. The position requires experience in Root Cause Analysis methodologies, Good Documentation Practices (GDP) in a regulated environment, and proficiency with various platforms including Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms. Strong technical writing/presentation abilities and excellent written/verbal communication skills are essential. The ideal candidate will be a team player, ethical, creative, and adept at using the scientific method.

Requirements

Bachelor's Degree with five (5) years of experience as a Scientist within the pharmaceutical or regulated industry.
Bilingual (English & Spanish).
Project Management skills.
Experience in Root Cause Analysis methodologies.
Experience in GDP (Good Documentation Practices) on a regulated environment.
Experience with Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms.
Technical Writing/presentation abilities.
Excellent written/verbal communication.

Nice To Haves

Multitasking skills
Scientific skills
Creative skills
Teamwork
Ethical conduct
Use of the scientific method

Responsibilities

Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions.
Provide troubleshooting support.
Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
Provide support of timely execution of the process monitoring quarterly reports.
Ensure that all Non-conformances are triaged within the established goal.
Responsible for authoring investigation reports.
Responsible for execution of corrective actions.
Responsible for managing NC/CAPA closure within established goal.
Monitor and communicate incidents trends.
Review equipment/system Root Cause Analysis investigations and support trend evaluations.