Location: Barceloneta, PR
Pay Rate: $38.62
Type of Position: Exempt Position
Assingment Duration: 6 Months

Purpose:

• The GMP Documentation Analyst will support GMP documentation and validation activities by preparing, reviewing, and maintaining protocols, reports, and other GMP-related documents. This position will also support process validation, Continued Process Verification (CPV), change controls, deviation investigations, technical transfers, and assigned process improvement projects under the guidance of a company employee.

Responsibilities:

• Prepare and support the generation of GMP documentation, including validation protocols, reports, special studies, memorandums, and other technical documents.
• Support the execution and documentation of process and cleaning validation studies, including periodic validations, new material validations, mixing validations, and other applicable studies.
• Support the Continued Process Verification (CPV) program by:
  • Evaluating assigned process parameters.
  • Identifying process trend signals.
  • Supporting the evaluation of potential process concerns and appropriate mitigations.
  • Updating the Control Strategy Summary as required.
• Support the generation and execution of assigned process and project-related documentation.
• Assist with project implementation and technical transfer activities as required.
• Support projects related to process validation, cleaning validation, process improvements, technology implementation, packaging, and other manufacturing initiatives.
• Participate in deviation investigations and Root Cause Analyses (RCA) to help identify and document appropriate root causes.
• Generate and manage change controls within the electronic system, including tracking approvals, execution, and closeout.
• Collaborate with cross-functional teams to gather technical information and accurately translate production processes and requirements into clear, compliant written documentation.
• Ensure documentation is accurate, complete, and aligned with applicable GMP requirements, procedures, and quality standards.

Qualifications/Requirements:

• Bachelor’s degree in Engineering, Chemistry, Pharmacy, Microbiology, Life Sciences, or a related scientific/technical field.
• Experience working in a pharmaceutical manufacturing or GMP-regulated environment.
• Experience preparing GMP documentation for pharmaceutical companies, including SOPs, protocols, special studies, memorandums, reports, or similar technical documents.
• Knowledge or experience with process and/or cleaning validation preferred.
• Familiarity with Continued Process Verification (CPV), process monitoring, trend analysis, and control strategies preferred.
• Experience with deviation investigations, Root Cause Analysis (RCA), and/or change controls preferred.
• Strong written and verbal communication skills with excellent attention to detail.
• Fluent in Spanish and English, both written and spoken.
• Strong organizational and planning skills, with the ability to manage multiple assignments and priorities.
• Must be organized, focused, curious, and creative, with the ability to translate complex or evolving production processes into clear and accurate written documentation.
• Ability to work effectively in a cross-functional and matrixed environment and collaborate with multiple stakeholders.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is $38.62/hr.