Location: Caguas, PR
Pay Rate: $20.29 / Hourly

Overall Responsibilities:
This position will provide Quality Assurance oversight to one or multiple operational areas as a
Quality Representative supporting the company operations. This role will perform all related quality activities as established on Company procedures and applicable regulations. The employee will provide guidance on compliance aspects and will actively participate in functional area goals regarding compliance. Provide information of updated compliance trends and follow up actions required for keeping the operation in compliance with regulations.

Primary functions: 

• Reviews and approves all procedures, protocols, reports and specific documents requiring the Quality Representative overview.
• Reviews and approves Manufacturing or Packaging records as required.
• Assures compliance on corrective/preventive actions as a result of events reports.
• Reviews and approves final investigations reports ensuring root cause was determined and CAPAs are being established.
• Performs the necessary statistical analysis (trend and variability analysis for capability evaluation) and prepares Quality metrics as required.
• Supports the Annual Product Review/ Quality Record Review schedule.
• Ensures product complaints are investigated and corrective actions taken.
• Provides support to new product transfers to the area being responsible to support. 
• Reviews and approves areas change controls. 
• Tracks areas open and overdue documents to ensure a final resolution is reached and action is taken to avoid a major compliance risk.
• Provides advice to the areas on how new guidances and regulations can be implemented into area procedures.
• Assists management during regulatory/compliance inspections (FDA, MHRA, ANVISA, DEA, etc.) and clients audits.
• Performs spot audits to functional area being supported in order to ensure compliance with the established procedures and documentation requirements, as well as CGMP regulations.
• Coordinates inspection activities with the clients, inspectors, regulatory agencies, and/or internal departments on quality related matters.
• Participates in new hires induction trainings and trains them in CGMPs.
• Participates actively in the prevention and identification of root causes for investigations or area discrepancies to pursue permanent corrective measures.
• Supports the manufacturing and release schedule as established in the Planning Meetings.
• Receives and process license renewals and/or follow up on renewal documents.
• Prepares required communications or reports to regulatory agencies (FDA, MHRA, ANVISA, DEA, etc.).
• Reviews and approves areas change controls.
• Ensures compliance of all site procedures reviewed for format and content accuracy.
• Performs other duties as assigned.

Minimum Requirements: 

• Bachelor’s Degree in Science, Engineering or a related field.
• Minimum of 1 to 2 years of experience working in the pharmaceutical industry.
• Strong knowledge in solid oral pharmaceutical and laboratory operations (depending on the functional area to support).
• Experience in validation concepts and activities (Process, Cleaning. Analytical Methods, Utilities).
• Knowledge of local, federal and international regulations applicable to the pharmaceutical industry.
• Experience evaluating investigations and discrepancies.
• Demonstrated success interacting with customers (internal, external).
• Fully bilingual in English and Spanish.
• Strong verbal, written and interpersonal communication skills.
• Strong communication skills (written and verbal).
• Must possess flexibility to respond to changing conditions and priorities.
• Organization, prioritization and planning skills.
• Must demonstrate the ability to problem solve.
• In depth understanding/knowledge of:
  • CGMP, EHS, other related regulatory requirements and Controlled Substance
  • Computer Literacy (Microsoft Office, Business Application)
  • Willing to work other shifts as per company needs.

 
 
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. This position’s starting pay is: $ 20.29/hr.