Jennifer Martinez Email & Phone Number

Chicago, Il, Us

Chicago, Il, Us

Bloomingdale, Illinois, Us

Plan, execute, and finalize new product development projects. Develop project plans and schedule to ensure timelines are met. Schedule kickoffs/meetings, create agendas, keep meeting minutes, and track action items for the project team. Coordinate project work in cross-functional teams – including planning, purchasing, supply chain, labeling, QC, QA, science/regulatory, R&D, and contract manufacturers/packers (as applicable). Provide updates to management and project stakeholders. Successfully launched 14 new unique item SKUs to date; projects in progress for 25 additional item SKUs.Currently managing 2 label and/or packaging transition projects for marketing. Managed packaging change project for essential oil product line.Currently managing LIMS implementation project.

Bloomingdale, Illinois, Us

Ensured product complaints were logged, investigated, and resolved according to established company and FDA deadlines. Conducted complaint investigations, including review and analysis of data and BPRs, preparation and submission of MedWatch reports for Adverse Events, submission of samples for laboratory analysis, and collaboration with subject matter experts from various to establish root cause and corrective/preventive actions. Provided complaint updates to management and compiled weekly/monthly complaint metrics. Conducted internal audits of Production areas. Reviewed and created master data entries in LIMS (Specifications, ATCs, Sampling Plans, Products, and Product Variants) throughout the various project stages in 2018-2019.

Bloomingdale, Illinois, Us

Audit QC Analytical Laboratory data to ensure compliance to testing methods and Good Documentation Practices (GDP). Test data includes, but is not limited to: HPLC, GC, LC-MS, HPTLC, Titrations, and UV-Vis. Review includes ensuring testing was performed as per the test method and results meet specification. Familiarity with Oracle, Doc Center (specification sheets), and labels as these are used to verify testing specifications, serving sizes, analytes, and test methods. Proofread and review method drafts undergoing revision to ensure compliance; issue training and route documents to QA to be made effective. Investigate out of specification and out of trend results with management. Complete investigation documentation and record results. Request product safety evaluations from the nutrition group if not completed or out of date. Perform on-the-job training as requested. Notable Contributions¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯• Active member of laboratory safety subcommittee. Served as team member, co-chair, and chair. Provided project management support to the team. Generated a project tracker to monitor team projects and action items. Coordinated team bulletin board branding and plan updates to the board to ensure message consistency.

Managed complaints from patients and doctors in accordance to FDA regulations. Conducted investigations, analyzed complaint data for trends, recommended applicable corrective/preventive actions, and followed-up with customers. Responsible for technical writing of complaint investigation reports and FDA MedWatch reports. Organized, compiled, and maintained the complaint files. Monitored change control process of departmental documents. Notable Contributions¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯• Reviewed and proofread marketing documents submitted to our department to compliance approval. Reviewed collateral for content and interpretation as per change control process and FDA requirements. • Established and led cross-functional teams to support process flow improvements pertaining to device evaluations and patient interviews. • Coordinated Corrective/Preventive Actions: Identified root cause, developed action plans with departmental representatives, scheduled meetings, and ensured proper execution.• Organized logistics of 09/2011 FDA Site Audit: Requested documentation, met with auditors, scribed notes on audit and close-out meetings, assisted in drafting response document, and conducted follow-up on action items.

Mumbai, In

Note: Wockhardt acquired MGP. I held three overlapping positions during my tenure with Wockhardt/MGP. Led complaint response activities for MGP and Wockhardt USA: Actively supported the customer hotline, submitted MedWatch reports, conducted investigations, reviewed and analyzed data, performed historical review, and managed/updated the complaint Access database. Reviewed reports from Medical Consultant and classified Adverse Event complaints per WHO terminology categories. Conducted literature reviews for possible MedWatch submission.Notable Contributions¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯• Developed systems to track complaints and refund requests submitted to Customer Service and Adverse Event after the acquisition by Wockhardt resulted in multiple departments. • Compiled complaint metrics measuring number of complaints and Adverse Events reported to the FDA for upper management and other departments including subsidiaries in India, New Jersey, United Kingdom, and Ireland.• Organized logistics of 09/2009 and 03/2010 FDA Site Audits: Compiled and controlled influx of requested documentation, met with auditors to review complaints, and provide subject matter expertise.

Parsippany, Nj, Us

Managed and tracked company training: reviewed records for accuracy, managed the training Access database, generated metrics to ensure employees were current on compliance training programs. Prepared training presentations and facilitated company-wide Quality and Current Good Manufacturing Practices training programs. Notable Contributions¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯• Directed training activities related to change control and followed-up to ensure timely completion of required SOP training. • Improved functionality and efficiency of the training database, achieved 100% compliance on monthly gap training metrics.

Mumbai, In

Researched, compiled, and analyzed data from product inception to completion (including after-market testing) as part of the cGMP requirement for Annual Product Reviews (APRs). Entered, verified, and analyzed testing data for accuracy and integrity. Notable Contributions¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯• Identified and reported trends in results and supported technical writing of protocols, study creation, schedule preparation, sample handling, and change control processes.

Taught two semesters of general art and one semester of biology to high school students in an alternative after-school/weekend program. Generated curriculum to stimulate the interest of at-risk students, including, but not limited to hands-on activities, projects, movies, lectures, group activities, and readings.

Abbott Park, Illinois, Us

Product Quality Assurance – Advanced Quality Technician, 07/2004 – 08/2005¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯Led implementation of stability studies for over 25 products: ordered materials, scheduled test dates, initiated testing paperwork, ensured testing completion, and tracked inventory. Developed tracking spreadsheets to increase efficiency of stability testing process and improve inventory management.• Responsible for coordination of complaint testing for over 40 products: ordered materials and served as liaison between departments on testing status.Analytical Quality Assurance – Advanced Quality Technician, 10/2001 – 07/2004 ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯Audited testing paperwork and instrument/equipment usage logs for compliance. Helped overcome production crisis in order to maintain on-market product availability. Collaborated with cross-functional teams and provided product testing support.• Maintained testing material inventory for over 30 testing materials and reagents.

Project Management Course (35 Hours)

Mba, Integrated Marketing Communications

Bachelor'S, Biology