Scientist

Company 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.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

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 manufacturing operations. This role is responsible for ensuring manufacturing processes are reliable, compliant, and capable of consistently delivering high-quality products, particularly within spray drying and solid dosage manufacturing environments.

The position requires strong collaboration with cross-functional teams and external partners to support process performance, resolve issues, and drive continuous improvement.

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 effectively communicate 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

Benefits

What We Offer

• Opportunities for learning, development, and professional growth.
• A collaborative and supportive work environment.
• The opportunity to work with industry-leading clients on impactful projects.

Your information will be kept confidential according to EEO guidelines.