Life Sciences Manufacturing Process Specialist

Inteldot

Juncos (PR)

On-site

USD 48,000 - 72,000

Full time

14 days+

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Job summary

Inteldot, a life sciences partner with over 15 years in Puerto Rico, seeks an Administrative/Quality Support role to help manage manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. Working with minimal supervision, you will act as document owner and support process ownership on complex systems.

The ideal candidate has strong technical writing, experience with Veeva Vault or similar platforms, change control

Qualifications

Knowledge of document handling on Veeva Vault (CDOCs) and similar platforms.
Technical writing expertise required for procedures and documentation.
Change control ownership and document ownership responsibilities.
Experience with project handling and coordination.
Familiarity with Smartsheet or similar platform.
Regulatory/GMP knowledge for regulated industries.
Understanding of cGMP compliance and documentation practices.
Bilingual in Spanish and English.

Responsibilities

Initiate, revise, and approve manufacturing procedures; ensure alignment with current operations; serve as document owner.
Assess process performance by observing floor operations and data review; plan and implement improvements.
Provide troubleshooting support for process issues.
Assist in creating training materials and delivering training on technical aspects.
Support process monitoring parameters and collection of data for deviations.
Assist with timely execution of quarterly process monitoring reports and CAPA closure.
Ensure non-conformances are triaged within established goals; author investigation reports and corrective actions.
Monitor incidents trends and support RCA investigations and trend evaluations.
Assist with generation of process validation protocols and reports; support execution of validation activities.
Participate in regulatory inspections, NPI processes, and equipment modifications.