Specialist Quality Complaints- PRQN796

Frey Consulting Group; Juncos (PR); Hybrid; USD 55,000 - 85,000; Full time

Job summary

Frey Consulting Group seeks a Quality Complaints Specialist to oversee product complaint investigations in a regulated GMP environment. You will manage investigations, trend data, and communicate findings to stakeholders.

The role requires strong analytical, technical writing, and project management skills, with the ability to translate complex investigations into clear documentation while collaborating across functions.

Qualifications

• Requires strong investigation and data analysis skills.
• Excellent written and verbal communication, with ability to prepare documentation.
• Experience with GMP quality systems and regulatory compliance.
• Demonstrated ability to lead cross-functional investigations.

Responsibilities

• Lead and manage product complaint investigations in GMP setting.
• Summarize and document investigations clearly and concisely.
• Update and maintain complaints database with timely information.
• Identify trends and potential signals from data analysis.
• Support RCA and CAPA as appropriate.
• Ensure timely escalation of high-risk issues.

Skills

Investigation

Data analysis

Technical writing

Project management

Cross-functional collaboration

GMP knowledge

Communication

Teamwork

Microsoft Office

Excel

Outlook

Microsoft Teams

Education

Master's degree + 2 years related experience

Bachelor's degree + 4 years related experience

Associate's degree + 8 years related experience

High School Diploma/GED + 10 years related experience

Tools

Microsoft Office

Excel

Outlook

Microsoft Teams

Job description

Tittle: Quality Complaints Specialist – PRQN-796

Work Schedule: Hybrid – Administrative Shift

Availability: Must be available to work different shifts and/or weekends as business needs require

Contract Duration: 5 months

Positions Available: 2

This opportunity is available only to direct individual candidates. Submissions from third-party contractors, staffing agencies, vendors, or Corp-to-Corp (C2C) arrangements will not be considered.

Position Summary

Our client is seeking a Quality Complaints Specialist to support the product complaint system within a regulated GMP environment. The primary responsibilities include leading and managing product complaint investigations, analyzing and trending complaint data, identifying potential signals, and supporting timely and appropriate actions.

The ideal candidate will have strong investigation, analytical, technical writing, project management, and communication skills. This role requires the ability to translate complex technical investigation findings into clear, concise documentation that can be understood by both technical and non-technical stakeholders.

Key Responsibilities

Product Complaint Management

• Support the product complaint management system and ensure complaint records are maintained accurately and in a timely manner.
• Keep the complaints database updated as factual information becomes available.
• Accurately summarize and document completed investigations within the complaint database.
• Lead and manage product complaint investigations based on the nature and complexity of each complaint.
• Review and approve complaint-related investigations to ensure they are:
• Concise and clearly written.
• Scientifically sound and evidence-based.
• Complete and appropriately documented.
• Compliant with applicable quality and regulatory requirements.
• Conduct and document investigations when assigned based on the nature and complexity of the complaint.

Investigation & Corrective Actions

• Apply strong analytical and problem-solving skills to assess product complaints and investigation findings.
• Support or perform Root Cause Analysis (RCA) as appropriate.
• Identify and support appropriate Corrective and Preventive Actions (CAPA) resulting from investigations.
• Follow up on corrective actions through completion and ensure appropriate documentation.
• Evaluate complaint information to identify potential trends, recurring issues, or signals requiring further assessment.
• Support timely escalation of significant or potentially high-risk complaint issues.

Complaint Data Analysis & Trending

• Perform data analysis and trending of product complaint information.
• Proactively identify potential signals and emerging trends.
• Communicate relevant trends and findings to appropriate stakeholders.
• Support data-driven decision-making and timely quality actions.

Technical Writing & Communication

• Prepare clear, concise, and scientifically sound investigation documentation.
• Translate highly technical investigation findings into documentation that can be readily understood by non-technical reviewers.
• Ensure investigation reports accurately communicate the facts, analysis, conclusions, and required actions.
• Communicate and escape product complaints as appropriate.
• Prepare and issue complaint closure letters to patients and business partners, as applicable.

Cross-Functional Collaboration

• Represent the site within the product complaint network, as needed.
• Lead and facilitate cross-functional discussions related to complaint investigations.
• Collaborate effectively with Quality, Manufacturing, Engineering, Supply Chain, laboratories, and other functional groups.
• Work effectively within a matrix organization and coordinate activities across multiple stakeholders.
• Manage multiple projects and priorities simultaneously while meeting established deadlines.

Education & Experience

Candidates must meet one of the following requirements:

• Master's degree plus 2 years of directly related experience; or
• Bachelor's degree plus 4 years of directly related experience; or
• Associate's degree plus 8 years of directly related experience; or
• High School Diploma/GED plus 10 years of directly related experience.
• Experience with project management, including the ability to coordinate multiple activities and priorities simultaneously.
• Experience leading or participating in cross-functional teams.
• Experience with Root Cause Analysis (RCA) and CAPA determination.
• Strong knowledge of GMP, quality systems, and compliance requirements.
• Excellent written and verbal communication skills.
• Strong technical writing and documentation skills.
• Strong facilitation and presentation skills.
• Ability to work effectively within a team-oriented, matrix environment.
• Ability to collaborate with diverse departmental groups and external resources.
• Strong analytical, problem-solving, decision-making, and influencing skills.
• Strong attention to detail and ability to prioritize tasks and meet deadlines.
• Ability to work independently while also contributing effectively as a team member.
• Ability to evaluate quality issues, make sound decisions, and determine when escalation is appropriate.
• Strong customer service and stakeholder management skills.
• Ability to communicate effectively with personnel at different organizational levels.
• Strong organizational and time-management skills.
• Proficiency with Microsoft Office, particularly Excel and Outlook.
• Proficiency with Microsoft Teams and other standard collaboration tools.
• Ability to independently understand, follow, and implement procedures and work instructions.

Preferred Background

Candidates with the following experience will be particularly well suited for the role:

• Product complaint investigation experience within a pharmaceutical, biotechnology, medical device, or other regulated GMP environment.
• Experience leading investigations from initial complaint assessment through final closure.
• Experience reviewing and approving complaint investigation reports.
• Experience performing complaint data trending and signal detection.
• Experience with RCA, CAPA, deviations, and quality investigations.
• Experience communicating investigation findings to technical and non-technical audiences.
• Experience working within a matrix-managed organization and leading cross-functional activities;
• Experience with quality systems and regulated product complaint processes.