Experience

AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Lead Manufacturing Technician

  • May 2021 - Present

  Worcester, Massachusetts • Works in a GMP environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulates and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority/FDA requirements. • Setting up manufacturing areas and equipment/fixtures by performing facility and equipment commissioning activities such column works. • Contributes to writing of batch… Show more • Works in a GMP environment and perform aseptic processing; maintain manufacturing environmental conditions (Non-Viable Particulates and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority/FDA requirements. • Setting up manufacturing areas and equipment/fixtures by performing facility and equipment commissioning activities such column works. • Contributes to writing of batch records/standard operating procedures that are technically sound to promote effective and efficient operations and comply with cGMP requirements. • Performs functions such as chromatographic skid operations, nano filtration, UF/DF filtration, depth filtration, viral inactivation, and other downstream purification procedures using software such as DCS, LIMS, and other support systems such as SAP etc. • Identifies, escalates, and documents events that deviate from normal operation and participate as needed in investigating the deviations. • Tracks and communicates progress and results related to projects/activities. • Review of documentation such as batch records for completeness checks as required by production and validation protocols. • Training of newly hired technicians on downstream processes, supporting activities and work instructions to successfully complete manufacturing operations. Show less



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Control Associate

  • Dec 2020 - May 2021

  Devens, Massachusetts • Independently perform routine and complex testing for chromatographic and spectrophotometric methods of analysis for excipients, new chemical entities and/or drug products. • Execute immunoassay testing on automated and semi-automated instrument platforms. • Accurately assess testing data to ensure product specifications are met and Device History Records are compiled in a compliant manner, according to current cGMP and site SOP’s • Executes routine procedures based on… Show more • Independently perform routine and complex testing for chromatographic and spectrophotometric methods of analysis for excipients, new chemical entities and/or drug products. • Execute immunoassay testing on automated and semi-automated instrument platforms. • Accurately assess testing data to ensure product specifications are met and Device History Records are compiled in a compliant manner, according to current cGMP and site SOP’s • Executes routine procedures based on methodologies/responsibilities, such as HPLC, UPLC, iCIEF, Capillary Electrophoresis (CE), and Gel Electrophoresis. • Perform routine testing and data review of batch release, and/or stability samples of Bulk Drug Substance in a cGMP compliant laboratory. • Ensure accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigations. • Compare laboratory data against specifications, prepare reports, and trend data where applicable to determine if results meet requirements. • Contributes writing of standard operating procedures, analytical testing procedures, final submission ready documents, and create document templates for use by junior team members. • Serve as a method troubleshooting resource to identify and document critical factors that affect method performance and assist peers in resolving method issues in a timely, cost-effective manner. Show less



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Lead Manufacturing Technician

  • Nov 2019 - Dec 2020

  Framingham, Massachusetts, United States • Responsible for prioritizing manufacturing schedule requirements within a fast-paced manufacturing operation with primary activities including but not limited downstream purification process and completes the appropriate batch records accordingly. • Identifies, escalates, and documents events that deviate from normal operation and participate as needed in investigating the deviations. • Assist in the creation and revision of standard operating procedures by providing input to technical… Show more • Responsible for prioritizing manufacturing schedule requirements within a fast-paced manufacturing operation with primary activities including but not limited downstream purification process and completes the appropriate batch records accordingly. • Identifies, escalates, and documents events that deviate from normal operation and participate as needed in investigating the deviations. • Assist in the creation and revision of standard operating procedures by providing input to technical composition of documents. • Worked on routine manufacturing assignments, measure and check raw materials and ensure team members are proficient in the operation of primary production equipment within the assigned functional area. • Supports validation, engineering, and facilities personnel in start-up, testing and operation of manufacturing process equipment. Show less



AutoZone

• United States
• Motor Vehicle Manufacturing
• 700 & Above Employee

• Parts Sales Manager

  • Sep 2014 - Dec 2019

  Shrewsbury, Massachusetts, United States • Managed all store operations to improve market penetration, provided excellent customer service, and generated an increased return on investment. • Worked with existing and new customers to generate revenue opportunity for the store and executed the plan to take advantage of the opportunities. • Planned workloads and assigned work schedules on a weekly basis. • Maintained a safe work environment and monitored store sales and profit performance daily. • Managed and… Show more • Managed all store operations to improve market penetration, provided excellent customer service, and generated an increased return on investment. • Worked with existing and new customers to generate revenue opportunity for the store and executed the plan to take advantage of the opportunities. • Planned workloads and assigned work schedules on a weekly basis. • Maintained a safe work environment and monitored store sales and profit performance daily. • Managed and protected company assets, including controlling store expenses. • Built and managed a store team and consistently deliver high levels of customer service and business results. • Defined problems, collected information, established facts, draw valid conclusions, and effectively resolve issues independently. • Drove AutoZone operational and marketing programs while steering toward continuous improvement in processes and procedures. • Led a successful team and manage our fast-paced retail stores. • Built, coached, trained, and engaged crew team to deliver superior levels of customer care and business results. • Acted as a consultative partner to commercial customers by maintaining expert knowledge on automotive parts and conducted research to guarantee the customer is offered the right part for the right price. Show less



Alpha Analytical

• United States
• Environmental Services
• 200 - 300 Employee

• Chemical Analyst III

  • Jun 2016 - Nov 2019

  Westborough, Massachusetts, United States • Trains new analysts on proper testing techniques and data processing. • Calibrate instrumentations and tracked instruments as required by quality control. • Oversee team of QC technicians and analysts through effective planning, mentoring, directing and coordination of development activity. • Serve as the secondary interface with internal/external client organizations to ensure timely and complete reporting, problem-solving and the highest level of service and… Show more • Trains new analysts on proper testing techniques and data processing. • Calibrate instrumentations and tracked instruments as required by quality control. • Oversee team of QC technicians and analysts through effective planning, mentoring, directing and coordination of development activity. • Serve as the secondary interface with internal/external client organizations to ensure timely and complete reporting, problem-solving and the highest level of service and responsiveness. • Ensure laboratory tests are accurately performed and results are reported in a timely manner. • Responsible for maintaining the integrity of work areas including maintenance and calibration of measuring and monitoring devices, general work center safety and cleanliness in compliance with established Quality standards. • Communicate and enforce laboratory quality requirements to all personnel working in the lab and ensure that they are completed per GMP, GLP, ISO 9001 and ISO 13485 standards. • Create, analyze, verify, and approve result reports and material release records. • Lead Out-of-Specification and NCMR investigations related to laboratory testing and procedural or analytical deviations or errors and ensure corrective actions are developed and implemented. • Facilitate periodic training of QC Technicians and Analysts to ensure standard adherence to laboratory practices, techniques, and adherence to cGLP and other applicable regulations and standards. Show less



Worcester Telegram & Gazette

• United States
• Newspaper Publishing
• 1 - 100 Employee

• Readership & Circulation

  • Oct 2015 - Jul 2016

  Worcester County, Massachusetts, United States • Coordinated online or print publishing cycle and some managed content areas for opinions and editorials page. • Set publication standards and established goals and expectations. • Suggested stories and generated opinions and editorials page headline ideas in alignment with targeted audience's preferences • Handled multifaceted clerical tasks (e.g., data entry, filing, and records management) as a news associate of the city editor. Quickly became a trusted assistant known for "can-do"… Show more • Coordinated online or print publishing cycle and some managed content areas for opinions and editorials page. • Set publication standards and established goals and expectations. • Suggested stories and generated opinions and editorials page headline ideas in alignment with targeted audience's preferences • Handled multifaceted clerical tasks (e.g., data entry, filing, and records management) as a news associate of the city editor. Quickly became a trusted assistant known for "can-do" attitude, flexibility and high-quality work. • Communicated effectively with the public and co-workers to ensure accurate information was printed. Established strong relationships to gain support and effectively achieve results. • Entrusted to manage office in the supervisor's absence. Provided timely, courteous and knowledgeable response to information requests; screened and transferred calls. • Earned outstanding marks on routine reviews, technical writing, with citations for excellence in areas including work volume, accuracy and quality; ability to learn and master new concepts; positive work ethic; and commitment to providing great service. Show less



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Specialist

  • Aug 2013 - Jun 2016

  Westborough, Massachusetts, United States • Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs. • Manage planned and unplanned deviations, investigations, change controls, CAPAs, and OOS investigations. • Assist operations by providing quality oversight and guidance for typical events assessing complex manufacturing issues for forward processing. • Perform walkthroughs of GMP areas documenting observations and areas of concern to support audit… Show more • Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs. • Manage planned and unplanned deviations, investigations, change controls, CAPAs, and OOS investigations. • Assist operations by providing quality oversight and guidance for typical events assessing complex manufacturing issues for forward processing. • Perform walkthroughs of GMP areas documenting observations and areas of concern to support audit readiness of the manufacturing facility and support areas. • Supports return to service walkthroughs and Manufacturing audit readiness walkthroughs per procedure as needed. • Actively support continuous process improvement to increase compliance and maintain a consistent state of laboratory controls. • Ensure all electronic and paper documentation that requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines. • Reviews, approves, and provides guidance for quality master data. • Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs. • Monitors and trends batch record errors, batch record review cycle time to support disposition, and walkthrough observations to provide QA management with quality indicator data. • Supports the Quality review and closure manufacturing deviations. Show less



North West Dept. of Education - Vaal Reefs Technical High School

• Head of Department/Teacher

  • Aug 2005 - Jul 2013

  Orkney, North-West, South Africa • Present chemistry and integrated science lessons to 110+ students of 10-12th grades. • Supervise the instructional programs of the department, evaluating lesson plans and tests, and observing classes on a regular basis to encourage the use of a variety of instructional strategies and materials consistent with research on learning and child growth and development. • Organize, manage, evaluate, and supervise effective and clear procedures for the operation and functioning of the science… Show more • Present chemistry and integrated science lessons to 110+ students of 10-12th grades. • Supervise the instructional programs of the department, evaluating lesson plans and tests, and observing classes on a regular basis to encourage the use of a variety of instructional strategies and materials consistent with research on learning and child growth and development. • Organize, manage, evaluate, and supervise effective and clear procedures for the operation and functioning of the science department consistent with the philosophy, mission, values, and goals of the school. • Implement laboratory activities based on scientific methodology, real-life chemistry application and class safety during the laboratory practice. • Foster a positive learning environment by incorporating team building activities and positive reinforcement techniques. • Provide opportunities for effective staff development that address the needs of the instructional program and needs of the staff, including workshops, conferences, visitations, and sessions in which the staff shared successful practices and strategies. • Preparation comprehensive lesson plans based on the updated curriculum from Dept. of Education. Show less



Adcock Ingram Pharmaceutical Company

• Associate Scientist

  • Sep 2003 - Aug 2005

  Midrand, Gauteng, South Africa • Work in collaboration with senior scientists in the development and optimization of processes for production of biologics at different clinical stages. • Engage in the execution of bench-scale experiments using high-throughput, shake flask and bioreactor cell culture systems to improve cell culture processes. • Work on the design and executed experiments interfacing mainly with upstream and occasionally with downstream and analytical personnel to achieve process development… Show more • Work in collaboration with senior scientists in the development and optimization of processes for production of biologics at different clinical stages. • Engage in the execution of bench-scale experiments using high-throughput, shake flask and bioreactor cell culture systems to improve cell culture processes. • Work on the design and executed experiments interfacing mainly with upstream and occasionally with downstream and analytical personnel to achieve process development objectives. • Handled clinical samples and performed microbiology work of BSL-1 and BSL-2 organisms including bacterial and viral strains. • Participate in the development of quantitative methods and immunogenicity assays for the evaluation of PK/TK, safety, and efficacy endpoints of nonclinical studies from platform and development programs. • Maintain detailed experimental records including experimental design, analysis, interpretations, and results in technical report in electronic laboratory notebook. Show less