Quality Systems Specialist Complaints

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We are searching for the best talent for a Quality Systems Specialist Complaints to be located in Gurabo, PR.

The Quality Systems Specialist – Complaints is responsible for ensuring that the handling of complaints complies with established company and corporate standard operating procedures, policies, rules, and regulations, as well as current Good Manufacturing Practice (GMP) guidelines.

Key Responsibilities:

• Collaborates with the Operations Department to facilitate the investigation of customer complaints.
• Conducts physical field sample receiving activities, including decontamination if necessary.
• Analyzes data to generate weekly metrics for the Quality System Complaints Department.
• Utilize statistical techniques to track and analyze processes.
• Edits, reviews, and approves QA System documentation, such as Work Instructions, Standard Operating Procedures, Reports, and forms, as required.
• Actively participates in projects, programs, safety and environmental training, cGMP, SOPs, and other activities to foster employee involvement and professional development.
• Escalate issues to the Site Quality Head, Senior Manager, and/or the Complaint Lead of the Quality Assurance unit.
• Actively engages in Credo initiatives.
• Proactively seeks improvements and welcomes new assignments.
• Support regulatory inspections by providing subject matter expertise and assisting with data gathering and evaluations.
• Participate regularly with management team to identify solutions to common issues and prioritize solutions.

Qualifications:

• A bachelor’s degree in engineering or a Science field such as Pharmacy, Chemistry, Biology, or a related discipline is required. An MA/MS/MBA or a related science degree is desirable.
• A minimum of 1 to 2 years of experience in Quality Complaint Investigation process in the pharmaceutical industry, preferably in QA compliance areas, with comprehensive knowledge and understanding of domestic and international guidelines, cGMPs, pharmaceutical manufacturing and packaging, and quality control activities for various dosage forms is required.
• Professional experience in Quality Assurance, Regulatory Compliance, or other related areas within a highly regulated industry, such as pharmaceuticals, food and dairy processing, or medical devices, is required.
• A thorough understanding of FDA regulations and requirements applicable to drug products, as well as international regulatory requirements, is essential.
• Extensive knowledge of cGMPs and compliance standards is required.
• Excellent technical writing skills, including the ability to organize information in a logical and coherent manner.
• Excellent oral and written communications skills and fully bilingual in both English and Spanish.
• Expert understanding of cGMP, Good Documentation Practices, and Regulations.
• Expertise in JSC document management and change control processes.