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.

., ., US

• 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.

., ., US

• 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.

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.

• 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.
• 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.

• 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.

• 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.

• 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.

• 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.

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.

• 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.

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

Bachelor Of Science (Bs), Biology, General