Jobs at PSC Biotech Corporation

Conducts biochemical and compendial QC testing under supervision, including flow cytometry, ELISA, PCR, and USP, JP, and EP analyses. Supports GMP documentation, data integrity, sample logistics, inventory, equipment maintenance, method troubleshooting, qualification activities, and OOS or deviation investigations. Maintains laboratory standards, reagents, supplies, and records while contributing to continuous improvement and following SOPs.

Develops and reviews computerized system validation plans, protocols, and reports. Performs risk assessments, impact analyses, change controls, and deviation investigations for validated systems. Ensures compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaborates with IT, Quality Assurance, and Manufacturing teams, maintains lifecycle documentation and traceability, and supports regulatory audits and inspections.

Manage end-to-end recruitment for consulting projects, including gathering requirements, sourcing internal and external candidates, screening applicants, coordinating interviews, facilitating offers, and advising on rates and work-pass requirements. Maintain candidate databases, CV folders, resource allocation records, trackers, and recruitment documentation. Prepare weekly recruitment reports and meeting minutes while supporting project managers and leadership with resource availability and candidate submissions.

Performs microbiological and environmental monitoring testing for product release in a cGMP pharmaceutical environment. Responsibilities include sample testing, data review, LIMS documentation, trend reporting, method qualification and validation, contamination investigations, equipment maintenance, SOP updates, audit support, analyst training, sample lifecycle management, and laboratory inventory coordination. The role also supports continuous improvement, process compliance, safety, and manufacturing operations.

Leads the creation of batch records and production SOPs, manages GMP change records, CAPAs, and continuous process improvements. Supports manufacturing operations through process planning, troubleshooting, root cause analysis, experimental design, and performance improvement. Coordinates small to medium projects, facilitates multidisciplinary teams, reviews GMP documentation, and implements changes to improve predictable, compliant production operations.

Supports GMP biotech manufacturing by performing equipment monitoring, laboratory sampling and measurements, sanitization, aseptic handling, CIP/SIP operations, troubleshooting, batch documentation, and LIMS sample submission. The role requires rotating 12-hour shifts, manual material handling, and adherence to SOPs, logbooks, batch records, and production schedules.