Joseph Barcia Email & Phone Number

Burlington, Nj, Us

Cranbury, New Jersey, Us

Waltham, Ma, Us

• Performed batch record review for intermediates and final drug products.• Supported client process change implementation by authoring or approving Change Controls, Protocols, and Standard OperatingProcedures (SOPs).• Conducted internal process audits to ensure compliance with established internal control procedures by examining records, reports, operating practices, and documentation.• Performed line clearance prior to manufacturing start.• Released raw material and drug product to support the manufacturing process.• Reviewed and approved deviations and CAPAs in Global Trackwise.• Maintained training compliance within Compliance Wire and Success Factors systems.

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• Evaluated Adverse Events and Product Quality Complaints. Processed cases in accordance with SOPs using PQMS for all global regions except Latin America.• Performed complaint investigations as needed per procedure.• Processed Priority product complaints per internal SOPs. Performed case review, trend analysis, return sample evaluation, investigation by manufacturing site and escalation, as appropriate. • Ensured all relevant data for complaints were obtained and well documented in accordance with closure timelines.• Collaborated with multiple internal and external business partners to ensure the integrity, consistency, compliance, and alignment of the end-to-end complaint vigilance process. • Completed Monthly product complaint trend analysis, Complaint Vigilance reports and presentations per established procedures. • Prepared and lead presentation for Complaint Vigilance Review Board on a rotating basis.• Prepared and issue Complaint Vigilance Review Board meeting minutes on a rotating basis.• Attended CAPA review board meetings and presented complaint related trends or issues.• Monitored Complaint Records in PQMS to ensure standard process were being followed and complaints were closed as required.• Prepared ad-hoc Complaint Vigilance reports to support business partners.• Reviewed and updated External Manufacturing Site Manage spreadsheet as needed.• Interacted with J&J affiliates to ensure investigations are conducted per established SOPs, when regional complaints needed to be investigated.• Performed Quarterly reports for seven External Manufacturing sites.• Pulled data and prepared power point presentations for various Quality Site Management Reviews (QMSR).• Team lead for 2017 project, Triage Process Differences; Scheduled Meetings, prepared meeting agendas, prepared and updated project spreadsheets and gap assessment, attended and presented at monthly project update meetings with senior management.

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• Conducted an initial review of the complaint record in PQMS.• If site investigation was required, the file was triaged and forwarded to the appropriate J&J internal site or EMQA for investigation.• Ensured that the complaint record contained all the required information prior to sending the record for site investigation or closure.• Trended and perform initial review of lot-specific alert limits for all Non-Priority Product Quality and Lack of Effect Complaints.• Interfaced and collaborated with various internal and external business partners including External Manufacturing, the Consumer Care Center and Medical Safety to attain any needed clarifications.• Verified the validity of the reported product lot numbers using SAP systems.• Monitored, prioritized, and coordinated triage activities related to Johnson & Johnson products in a timely manner and in compliance with Current Good Manufacturing Practices (cGMP) and Johnson & Johnson Consumer Inc. Standard Operating Procedure (SOP) requirements.• Communicated with other complaint analysts and complaint investigators to ensure thorough, robust, and timely triage of complaint investigations.• Maintained training compliance within Compliance Wire (CW).• Team lead for 2017 project, Triage Process Differences; Schedule Meetings, prepare meeting agendas, prepare and update project spreadsheets and gap assessment, lead meeting discussions, Attend and present at monthly project update meetings with upper management.

Us

• Conducted an initial review of the complaint record in PQMS.• Ensured that the complaint record contained all the required information prior to sending the record for site investigation or closure.• Trended and performed initial review of lot-specific alert limits.• Data mined and reviewed complaint triage correction requests on a monthly basis for the entire triage team. Maintained Excel spreadsheet with custom graphs detailing correction trends.• Responsible for daily Change Log receipt and review by determining the impact to complaint investigation per established SOPs.• Actively monitored McNeil US OTC E-Mailbox to assure complaint attachments and Medwatch reports were processed on a timely basis.• Interfaced and collaborated with various internal and external business partners including External Manufacturing, the Consumer Care Center and the Office of Consumer Medical Safety to attain any needed clarifications.• Verified the validity of the reported product lot numbers using McNeil SAP systems.• Monitored, prioritized, and coordinated triage activities related to McNeil products in a timely manner and in compliance with Current Good Manufacturing Practices (cGMP) and McNeil Standard Operating Procedure (SOP) requirements.• Communicated with other complaint analysts and complaint investigators to ensure thorough, robust, and timely triage of complaint investigations.• Maintained training compliance within Compliance Wire (CW).• Reviewed and approved PQMS files as a Qualified Complaint Approver.• Active member of the Consumer Harmonization team working to synchronize with JnJ Consumer Complaint Vigilance.• Team leader the Alta/McNeil CCC Connect meetings• Active member of the McNeil Credo Development Team• Assisted in the training of new Complaint Triage Analysts

• Wrote and revised scientific and technical specifications for products, processes, and services for internal and external (Third Party Manufacturer) use.• Updated formula release testing specifications in electronic system (GSS) often managing and tracking approval status of 20+ specifications at a time.• Wrote and managed change control documents in electronic system (EtQ) with each change control document containing rationale for changing groups of 20+ specifications at a time.• Collaborated with various business partners including Quality Assurance, Supply Chain Management, Brand Management, Product Development, Technical Assurance, Analytical and Regulatory teams on a frequent basis to ensure the product specification revisions were changed to meet their needs and were rerouted for approvals. • Maintained a detailed MS excel spreadsheet of each specification under revision, detailing status in EtQ and GSS ensuring all changes are completed and documents are approved in timely manner.• Contributed to marketed product “test method suitability” gap closure project.• Actively participated in preparation for, execution of, and follow-up items from laboratory audits. • Maintained training compliance within Compliance Wire (CW)

• Lead Microbiologist collecting microflora samples from human subjects via Williamson-Kligman cup scrub technique.• Diluted and plated samples on various agars for microbial recovery; collected and calculated total count data using MS Excel.• Performed in-vitro test methods including Microbial Kill Time, Minimum Inhibitory Concentration, Neutralization Validation in support of formulation development and optimization in clear skin product category.• Communicated with multi-functional team to align subject visits, utilized SharePoint for data sharing and activities tracking, • Cultivated anaerobic bacteria (P. acnes) and maintained anaerobic chamber including gas cylinders and airlock.• Managed daily laboratory needs by ordering consumables, stocking supplies and media, and performing media growth promotion. • Maintained the temperature-monitoring system for all critical equipment; documented, explored and determined root cause for non-conformance events of temperature excursions including impact to active studies.• Complied with GLP/GMP regulations through good documentation of protocol and research studies in laboratory notebooks.• Maintained training compliance within Compliance Wire (CW)

•Responsible for the assaying and data interpretation for several internal J&J projects.•Responsible for testing the efficacy of several hundred formulations, meant to inhibit inflammatory response to inflammatory stimuli, in the skin.•Identify and quantify cytokines in treated skin equivalent samples by means of Millipore’s Multiplex bioassay, coupled with the Luminex xMAP platform.•Perform forward sequential competitive enzyme immunoassay to measure PGE2 in tissue culture supernatants. •Determine cellular cytotoxicity of treated skin equivalent samples by quantitatively measuring lactate dehydrogenase.•Perform peroxidase assay on tissue culture supernatants to determine peroxidase activity of formulations.•Assist with skin pigmentation studies by treating skin equivalents with formulations and subsequently quantifying melanin, measuring reflectance with chromatometer, and observing cells under inverse microscope.•Manage daily laboratory responsibilities such as ordering of consumables, and stocking supplies.

•Perform research to identify agonists and potentiators of the T1R1+3 GPCRs and of the T1R2+3 GPCRs thus modulating the umami and sweet taste sensations respectively. •Responsible for the maintenance of six inducible mammalian cell lines using aseptic techniques.•Perform cell based calcium flux high throughput in-vitro screens on FLIPR to identify lead compounds active on biological targets. •Develop and run Dose Response Curves as well as secondary screens for biologically active targets.•Analyze in-vitro data using excel and Graphpad prism.•Maintain a regularly updated laboratory notebook.•Responsible for all general lab management which includes but is not limited to reagent, and equipment purchasing and maintenance.•Developed a new wash protocol for existing assay using biotek EL406 automated washer.•Responsible for all troubleshooting if assay performance deviates from normal.

•Performed research on modulators of TRPM5 ion channel to discover novel taste enhancers and aversive taste blockers.•Performed high-throughput in-vitro pharmacological screens on multiple large and small libraries.•Ran plate reader based ion imaging assays for ion channel using FLIPR.•Assisted in hit conformation phase of hit to lead process.•Analyzed in-vitro data using excel based software (ceuticalsoft).•Kept a regularly updated notebook.•Maintained and troubleshot Platemate and Platemate 2x3 (Matrix technologies) instruments.•Biosafety officer for company: Duties included- Attended all safety committee meetings, perform quarterly safety inspections, set up shipment of all biological substances, reviewed all shipment documents.•Administrator of Controlled Substance program: Duties included- Set up program with DEA, Reviewed all related protocols for accuracy.

Switzerland 🇨🇭 , Ch

•Perform release and stability functional testing of raw materials and PCR IVD components and test kits including: HBV, HCV, HIV and DNA products. •Manual testing performed by specimen preparation, PCR amplification, hybridization and detection by ELISA.•Automated extraction and detection performed with aid of: COBAS TaqMAN for Real-time PCR, COBAS AmpliPrep for RT-PCR and COBAS AMPLICOR for PCR Amplification and Detection.•Work daily in BL2 laboratory environments, conforming to GLPs, ISO and OSHA guidelines.•Perform value assignments/range assignments for quantitation standards and positive controls.•Maintain test data and document laboratory activities using the Watson/LIMS system.•Communicate status of completed product release testing in SAP.•Assign product shelf life and generate stability records to recommend and support shelf life extensions.•Write and revise material specifications, directions for testing and SOP’s.•Train laboratory analysts to perform high complexity PCR tests and to maintain test data.•Report and investigate out-of-specification results and material nonconformances.•Participate in test method and process validation studies.•Ensure laboratory equipment is maintained, calibrated and/or validated on a prescheduled basis.

•Collect and perform microbiological analysis on environmental samples.•Perform laboratory procedures including: media and solution preparation.•Prepare, analyze and measure starting components of drug chemicals.•Perform compounding to produce final drug component.•Measure product amounts for yield calculations and maintained laboratory notebooks.•Extensive knowledge of USP/EP guidelines, cGMPs and GLPs.•Performed sterilization of equipment by means of autoclave and sonication.

Master Of Science (Ms), Cell/Cellular And Molecular Biology

Bachelor Of Science (Bs), Biology, General