Harba Solutions Inc.

Compensation

Full Description

Primary Responsibilities • Conduct testing of finished products, perform environmental monitoring, and carry out sterility quality control evaluations, documenting and reporting results accurately. • Identify and escalate any non-conformances or deviations, managing these quality issues in accordance with established procedures. • Assist with investigations related to deviations, OOS/OOT/OOE events, CAPA follow-ups, and implementation, as well as participate in Change Control activities including updating procedures and forms. • Participate in required qualification or validation projects as assigned. • Complete all mandatory training programs on schedule, covering SOPs, aseptic techniques, gowning protocols, testing methods, specifications, and health, safety, and environmental (HSE) requirements for the role. • Prepare and maintain relevant documentation, forms, and records, such as analytical batch records, in alignment with Good Documentation Practices. • Provide support during internal and external audits or inspections, as needed. • Required Qualifications • Education: Bachelor’s degree in a relevant scientific field such as Microbiology or Chemistry. • Experience: 0–2 years in a cGMP or aseptic manufacturing environment preferred. • Knowledge of cGMP regulations and FDA guidance relevant to QC testing, environmental monitoring, and aseptic techniques. • Hands-on experience with microbiological testing, method verification, routine QC assays, and environmental monitoring; understanding of method and equipment validation principles preferred. • Familiarity with HPLC techniques is required. • Ability to analyze and interpret test data and translate it into technical documentation. • Foundational understanding of aseptic principles and techniques. • Experience in quality control sampling and testing. • General knowledge of health, safety, and environmental protocols.