Quality Assurance (QA) Manager

• EDUCATION: B.S/Pharmacy Degree in Pharmacy with License (required).
• EXPERIENCE: Three+ years of experience in pharmaceutical or distribution industry (required).
• Three+ years of experience in a leadership responsibility/supervisory role. (required).
• SKILLS: Proficiency in Microsoft Office 365.
• Fully bilingual (English and Spanish) (required).
• Proficiency working with SAP and EtQ (or related QMS software) preferred.

• Ensures full compliance with regulatory body requirements such as Pharmacy (Licencia Botiquin), ISO, FDA, DEA, and DOT.
• Responsible for issuing supplier nonconformance alerts for corrective action.
• Drives process improvement.
• Manages and implements all product quarantine and product recall procedures.
• Liaison with QA Corporate to work with suppliers and manufacturers to determine corrective action requirements.
• Performs supplier qualification audits and assesses the effectiveness of correction action on behalf of Avantor and its customers.
• Provides risk assessment and notification to both legal and Senior Management.
• Assure that Avantor pharmaceutical related materials are properly received, storage and shipped.
• Authorized Avantor signature to signed inventory official documents.
• Works closely with local management team to plan, schedule, and implement QA and Regulatory related activities.
• Prepares routine and special reports to staff, and regulatory agencies as required.
• Assures merchandise document compliance and filing.
• Coordinates or develops and approves standard operating procedures for the area of responsibility.
• Prepares and/or maintains computer programs for the compiling and statistical analysis of quality assurance data.
• Answers product questions and serves as a Technical Specialist for the Sales Department, in his or her area of expertise.
• Responsible of the internal and external audits related to Puerto Rico Pharmacy Law.
• Evaluates quality events, investigations, discrepancies, and possible complaints and presents corrective and preventive actions reports.
• Plans, implements, and maintains procedures for packaging, and labeling pharmaceuticals, according to policy and legal requirements, to ensure quality, security, and proper disposal.
• 5-10% travel. Travel may include: Costa Rica and the continental United States, but may travel to other countries, if needed.
• Performs other duties as assigned.

• Knowledge in GMP, FDA, GLP and ISO regulations, required.
• Ability to develop highly effective relationships with associates, customers, vendors and senior leadership.
• Strong communication and interpersonal skills — verbal, written and presentation; comfortable with interaction with all levels of the organization.
• Excellent relationship building, reporting, and analytical skills.
• Ability to successfully manage multiple initiatives at the same time.
• Self-motivated with strong initiative skills
• Driver's License, Required,

• Typically works in an office, laboratory environment and process areas (warehouses and outdoor areas) with adequate lighting and ventilation and a normal range of temperature and noise level.
• Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems. A frequent volume of work and deadlines impose strain on routine basis.
• Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 20 Ibs.
• Personal Protective Equipment Required: Safety Shoes, Respirators and Gloves, safety glasses, and lab covers.

• This position may necessitate occasional travel (domestic and international) to client locations, conferences, or other relevant destinations as part of job-related responsibilities. Travel requirements may vary but are typically anticipated to be 5-10%.

Avantor