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After a little over a year, I was promoted to Principal Compliance Specialist. Support to the lab continued as described below, but with an added weekly teleconference call between the lab and QA (where a workload spreadsheet was reviewed), as well as an “Office Hours” session where lab analysts could approach QA with questions, guidance, or documents for review/approval.I also provided QA support to the Stability & Statistics department, mainly reviewing SOPs, GOPs, and training materials. Those Stats folks sure know their stuff!Keywords: promotion, stability, statistics, training material, technology transfer, change control, laboratory equipment qualification, gap analysis, remediation plan, spreadsheet

Through networking at my previous job, I secured this position in quality assurance. I provided QA oversight for a quality control lab focused on the development and validation of test methods. Since I had previously worked as an analyst in a similar type lab, I already understood the requirements and demands of such a lab.In support of our internal audit program, I became an American Society for Quality Certified Quality Auditor (ASQ-CQA). My involvement in the internal audit program began once I was promoted to Principal Compliance Specialist.Keywords: ASQ-CQA, auditor, auditing, documentation review, investigation, procedure, test method, protocol, report, user requirements, detail-oriented

Plot twist! After getting married in 2009 and moving to Boston, MA, I had to leave my previous job in New Jersey. After working 7+ years in a laboratory, I decided to put my lab experience to good use in a different way, in Quality Assurance. I was hired as a contractor and started gaining valuable experience reviewing batch records and QC test results. Unfortunately the company wasn’t doing well financially, but through my connections at this job, I was able to land my next one…Keywords: quality assurance, radiopharmaceuticals, CMO, batch record release, document review, deviation management, networking

After four years working in quality control, I decided to switch over to the method development and validation side of our organization when an opportunity emerged to work on a new, innovative product. It was a collaborative effort with a sister Johnson & Johnson company. For four months I was embedded in the other company, fostering communication and the exchange of ideas. Although my work on this particular project only lasted 18 months, it was by far the most interesting lab work I’ve done to date and am proud that the product eventually obtained FDA approval.Keywords: analytical, method development, method qualification, method validation, technical support, troubleshooting, innovative, clinical trials, FDA, inspection, presentationLab Skills/Tests Performed: friability, thrombin activity, excipient HPLC analysis

After about two years, I was promoted to Associate Scientist. While my main responsibility was still testing product, the number of assays on which I was trained increased as well as their complexity. I was adept at TrackWise, our quality system used to document deviations, investigations, and CAPAs, and became a super user of the system. As a super user, I trained new users as well as helped existing users with day-to-day navigation.Keywords: protein, large molecule, nonconformance, multitask, documentation & organizational skills, training, trainer, teamwork, leadershipLab Skills/Tests Performed: HPLC, peptide mapping, N-terminal sequencing, size exclusion chromatography (SEC), Dionex, sialic acid analysis

This was my first job out of college (although, I had previously interned in this laboratory in 1999). It was a typical entry-level job as a quality control analyst in the wet chemistry group, testing product for stability and release following cGMPs.The coolest part of this job was interacting with manufacturing for investigations. Sometimes it meant I got to gown up and go down to manufacturing!Keywords: biotech, biologics, quality control, QC, chemistry, USP, EP, compendial, commercial product, raw material, bulk drug substance, finished product, quick learner, customer focused Lab Skills/Tests Performed: pH, volume in container, total organic carbon (TOC), visual examination, conductivity, heavy metals, nitrates, sodium and chloride ions, particulate analysis, omolarity, melting point, isoelectric focusing gels (IEF), SDS-PAGE, Western Blot, protein concentration, infrared spectroscopy (IR)