TS/TM Scientist

QRC Group, Inc; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

QRC Group, LLC is seeking a highly skilled Scientist in Technical Services / Manufacturing Science (DRY-EM TS/MS) to provide scientific and technical support for spray dry dispersion, solid oral dosage manufacturing, technology transfer, process validation, and ongoing manufacturing support with external partners.

This role requires strong regulatory knowledge, data‑driven problem solving, and the ability to collaborate with internal and external stakeholders to maintain a compliant, in‑spec,

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, or Engineering.
• 5+ years hands-on spray dry and solid dosage manufacturing experience.
• Working knowledge of cGMPs and global regulatory guidance.
• Strong technical writing and documentation skills.
• Excellent communication and cross-functional collaboration abilities.
• Willingness to support 24/7 operations across time zones.

Responsibilities

• Provide technical oversight for spray dry, solid dosage manufacturing and packaging processes.
• Participate in resolution of technical issues related to control strategy and manufacturing.
• Author deviations and change controls with clear, compliant documentation.
• Manage internal and external relationships with partners and cross-functional teams.
• Support process validation, technology transfer, and external partner manufacturing.
• Ensure processes are compliant, in control, and maintained in a validated state.
• Document state of process validation with data on process capability.
• Maintain compliance with US and global regulatory guidance (cGMPs).
• Support 24/7 operations across multiple time zones as needed.

Skills

Strong communication

Technical writing

Project management

Collaboration

Bilingual English/Spanish

Education

Bachelor's degree in Chemistry, Pharmacy, or Engineering

Job description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Job Description

We are seeking a highly skilled Scientist in Technical Services / Manufacturing Science (DRY-EM TS/MS) to provide scientific and technical support for spray dry dispersion (SDD), solid oral dosage manufacturing, technology transfer, process validation, continued process verification, deviation investigations, and manufacturing support activities performed by external manufacturing partners. This role requires strong technical expertise, regulatory knowledge, and the ability to collaborate with internal and external stakeholders to maintain a compliant and reliable supply of pharmaceutical products.

Key Responsibilities

• Provide technical oversight for spray dry, solid dosage manufacturing and packaging
  processes, leveraging a strong technical foundation and previous experience supporting these processes.
• Participate in resolution of technical issues, including those related to control strategy and manufacturing.
• Possess excellent technical writing capabilities, including authoring of deviations and change controls.
• Employ excellent communication skills to manage internal and external relationships with external partners, site management, and cross‑functional teams.
• Build and maintain relationships with development and central technical organizations.
• Ensure that manufacturing processes are compliant, capable, in control, and maintained in a validated or qualified state.
• Understand, justify, and document the state of process validation with data that evaluates the capability of the manufacturing process to meet its stated purpose.
• Maintain processes in a state of compliance with US and global regulations, including cGMPs and applicable global regulatory manufacturing guidance.
• Support ongoing manufacturing at External Partners through process monitoring, issue response, and process improvements where necessary.
• Support technical transfer and validation activities to external partners manufacturing and packaging sites.
• Work cross‑functionally within the site and other functions to deliver on technical objectives.
• Some flexibility may be required to support 24/7 operations and issue resolutions with external partners across different time zones.

Qualifications

• Bachelor's degree (minimum) in scientific disciplines of Chemistry, Pharmacy, or Engineering.
• 5+ years of demonstrated hands‑on working experience and proficiency with spray dry, solid dosage manufacturing and packaging.
• Working knowledge of regulatory expectations (cGMPs and applicable global regulator guidance).
• Strong understanding of regulatory requirements and their application in a manufacturing environment.
• Proficient in data management practices across manufacturing and packaging operations.
• Proven ability to communicate effectively and influence across diverse technical and business teams.
• Demonstrated project management expertise with a track record of coordinating and executing multifaceted projects.
• Demonstrates adaptability, a collaborative mindset, and a positive attitude toward change.
• Available to support 24/7 operations and issue resolutions across multiple time zones as needed.
• Fluent in English and Spanish, with the ability to communicate effectively across diverse teams and stakeholders

Additional Information

All your information will be kept confidential according to EEO guidelines.

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