Marisel Acosta Email & Phone Number

San Germán, PR

Franklin Lakes, New Jersey, US

Irvine, CA, US

Minneapolis, MN, US

• Manage and/or lead the QA Microbiology Data Review team including responsibilities on on-going projects within laboratory, qualification of lab equipment, development, and validation of laboratory test methods.
• Plan assigned operational and project activities with the accountability for successful completion of assigned deliverables.
• Lead the execution of QA Microbiology Data Review activities to support project management and client delivery in accordance with applicable regulations, standards, and guidelines.
• Analyze metrics for the organization to drive efficiency and results.
• Identify opportunities and lead the implementation of changes to drive improvements.
• Actively participate in the OWR Bi-Weekly Meetings to help drive consistency and assure delivery on-time to clients.

Minneapolis, MN, US

• Assure all work performed is compliant with current FDA GLP's/GMP's regulations and Standard Operating
• Procedures (SOPs)
• Oversee and verify Quality Control practices within the laboratory
• Perform the development and revisions of SOPs, document change control, external and internal audits, training,
• Out-of-Specifications, Deviations and Laboratory Investigations including trending and documentation review for compliance with general regulatory requirements
• Support the development and implementation of the quality systems to avoid and eliminate non-conformances and evaluate possible corrective action plans after a regulatory activity.

Miami Lakes, FL, US

• Assured that the Quality System Audit function complies with QSR/GMP and ISO 13485 requirements. Performed internal audits for compliance to applicable government regulations, international standards and to company.
• Reviewed audit responses and assists with required training in response to audit findings and other QSR/ISO related issues as needed. Monitored the effectiveness of corrective action responses.
• Served as consultant to areas other those audited by them, making recommendations for corrective actions, which are required regarding audit results, and compliance to written procedures or applicable government.

• Managed the execution of the Nonconformance and CAPA process in terms of compliance to current procedures, regulations and business results. Evaluated and approved all documents related to CAPA System
• Supported the development and implementation of the quality systems to avoid and eliminate nonconformances and evaluate possible action plans after a regulatory activity.
• Maintained and escalate the quality metrics of the Nonconformance and Final Disposition Areas.
• Administered the Non-conformance system, and Corrective Actions of the site. Implement the CEWS and SAP (Quality Notifications) systems in the San German Site.

• Audited the manufacturing process (packaging, weighing, compounding, aseptic filling, washing, sterilization, lyophilization and shipping) for ophthalmic, parenteral and biologics products.
• Performs product Acceptance Quality Level (AQL) during inspection (parenteral products) stage and distribute reserve and/or stability samples to the appropriate area.
• Develops sampling plans based on acceptance quality level criteria when additional or special testing is required.
• Evaluate compliance of the documentation related to the manufacturing and support areas with government regulations and company policies and procedures. Document and investigate any discrepancy found.
• Performed disposition for finished products, raw materials and updates SAP system with batch status when required.

• Responsible to perform the product, environmental and utilities assays according to the appropriate SOPs and Test procedures. (Ex. LAL Test, surface and Air monitoring, Swabs BI’s and Bioburden tests). Performed minor.
• Support Media Fills activities in order to assure that typical and atypical interventions are performed as established.
• Supported investigations, such as NCR’s, ALF’s and Validations.
• Participated in the micro Data Management Green Belt Project and responsible for the development of a system to audit the Microbiology laboratory operations.

• Verified, approved and release finished product documentation including analytical, microbiological and raw materials testing data.
• Generated certificates of compliance, manufacturing, analysis or release based on current customer’s requirements.
• Investigated customer complaints, collected and reviewed data for Product Annual Review.
• Provided technical support during FDA inspections and International Government audits.