Edgar Mangual Feliciano

Manage team and ensure cGMP compliance of the laboratory area and operations under responsibility.

• Create a positive and collaborative team environment, and ensure that Company standards are met.
• He manages performance and provides technical guidance, coaching, and support to team members.
• Assigns training requirements and monitors training status of assigned team members.
• To create team plans, ensure resources are properly allocated and utilized effectively.
• Ensures all equipment used for GMP testing is in a qualified state.
• Reviews and approves GMP documentation, such as laboratory procedures, work practices, plans, protocols, and reports.
• Supports and maintains Lean Laboratory initiatives including 5S, deviation minimization, Right First Time, and inspection readiness.
• He actively participates in regulatory inspections.
• Report metrics to monitor schedule progress and help identify risk areas.
• To support purchase requisitions and purchase orders, they are managed appropriately to ensure business needs are met in a timely manner.
• Assignment of tasks and responsibilities to laboratory personnel.
• Coordination and supervision of the technical and administrative activities of the laboratory.

Oversee QC incoming material, in-process, and bulk product testing activities.

• Collaborate cross-functionally and interdepartmentally to define testing priorities, assign work to team members, and monitor progress against schedule.
• Review and approve documentation as required by laboratory procedures.
• Perform final approval and disposition of QC results.
• Provide technical support to QC team members.
• Oversee sampling plan and testing regimes for all incoming materials.
• Work to improve efficiencies through process improvements.

Support Deviations, Investigations, and Change Control Management.

• Ensures deviations, CAPAs, and change controls are handled appropriately and in a timely manner. Initiates and/or implements changes in controlled documents.
• Perform initial evaluation, checklists, and direct triage to determine if situations in the laboratory should proceed as investigations.
• Support the investigator during the investigation process.
• Ensure timely and compliant closure of QC deviations/investigations and CAPAs according to the company's procedures.

Promotes safe practices and behaviors.

• Report immediately incidents to Environmental Health and Safety (EHS) department, participate in investigations and identify measures to prevent similar accidents in the future.
• Promotes safe practices and behaviors, ensures that EHS requirements are implemented and respected.

• Performs required queries on SAP, Trackwise, and Infinity System to provide evidence of document closing disposition time.
• Evaluates and improves departmental procedures to ensure they are up to date with current practices or GMP trends.
• Audits executed manufacturing and QC Laboratory documentation.
• Revises vendor's certifications for completeness and compliance with company and GMP's requirements.
• Evaluates product incidents and deviations for conclusions as to the product's dispositions.
• Evaluates executed batch records.
• Coordinates priorities to ensure timely product release.
• Prepares certificates of analysis (CoA’s, COM’s, CoC’s) for products for sale according to Market requirements.
• Generates rejection labels and rejected material as needed.

• Reviews analytical data for compliance with GMPs, internal Company Policies & Directives, validated Analytical Methods, and Testing Standards.
• Manages the receipt and login of finished product and raw materials samples in the LIMS System.
• Authorizes tests and samples in laboratory systems such as LIMS and Empower, and certifies the analytical results required for finished product and raw material disposition.
• Provides support in the generation and approval of certificate of analysis for raw materials, packaging components, and finished products.
• Coordinates Laboratory schedule with Laboratory Analyst to maintain the work schedule according to the established business priorities and due dates with Supply chain, Laboratory, Product Disposition, and Manufacturing.
• Verifies and assures completion of laboratory testing schedules, ensuring due dates are met.
• In charge of the Chemical Laboratory during the absence of the Chemical Laboratory Manager, reporting to the Associate Director, QC Labs.
• Support Chemical Laboratory Manager, training Lab Analysts on techniques and procedures.

• Performs laboratory chemical and physical tests on materials of Raw Materials and Finished Product. (e.g. Description, IR, KF, HPLC, Dissolution, among others).
• Prepares testing reports in a neat and organized manner, including all pertinent calculations, raw data, information, and following the laboratory written procedures for reporting data.
• Assists in new laboratory personnel training when required.
• Works with LIMS Systems and any laboratory's computer system.
• Developed new ideas and suggestions to improve laboratory efficiency.

• Monitoring in-process reactions.
• Analyze decontamination samples (rinses & swabs).
• Laboratory Inspection.
• Standards Inventory.
• Verification of Laboratory Documentation.