Specialist Quality Complaints (Contract 32693) – Juncos, PR

Requirements Education & Experience

Doctorate Degree OR

Master’s degree & 3 years of quality / Manufacturing experience OR

Bachelor’s degree & 5 years of Quality / Manufacturing experience OR

High school diploma / GDE & 12 years of Quality / Manufacturing experience


Preferred Qualifications

  • 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor’s Degree in a Science Field
  • Ability to oversee multiple projects simultaneously
  • Ability to successfully manage workload to timeliness
  • Familiarity with basic project management tools
  • Ability to negotiate a position after taking feedback from multiple sources
  • Demonstrated ability to consistently deliver on-time, and high-quality results
  • Ability to operate in a matrixed or team environment
  • Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device Manufacturing processes)
  • Ensures quality of complaint records, consolidated / trend investigations
  • Facilitate cross-functional meetings to plan and coordinate the plan for closure of records
  • Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
  • Executes against prioritized work plans
  • Quickly escalates issues that could impede the ability to close records according to action plans
  • Maintains compliance with local and global processes
  • Follows procedures and regulatory requirements
  • Reviewing and acknowledging information contained in product complaint records
  • Determining if additional information is required to assign appropriate investigation requirements
  • Determining if return samples are required and following its status
  • Reviewing and approving assessments supporting the investigation
  • Conducting and leading cross functional team meetings to determine investigation requirements to be assigned based on event
  • Completing historical data analysis and trend evaluation assessments
  • Voiding records if required
  • Completing customer feedback records if required
  • Own consolidated/trend investigations until closure, if required



Primary responsibilities include: Supporting the product complaint system through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.


– Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.

– Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.

– Follow-up on corrective actions derived from investigations through completion.

– On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation.

– Therefore, the candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.

– May also include: Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.



– Doctorate degree or Master’s degree and 3 years of directly related experience to the job or Bachelor’s degree and 5 years of directly related experience to the job or Associate’s degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.



– Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously is a must.

– Excellent written and verbal communication skills, including facilitation and presentation skills.

– Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups.

– Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.

– Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to escalate, as necessary.


Administrative Shift