Position Overview
QC Analyst in the QC In Process Control team, located in a 5S certified analytical laboratory. This role offers exposure across both Drug Substance and Drug Product manufacturing in a highly compliant GMP environment.
Key Responsibilities
Perform primary review of QC raw data and trend results.
Prepare protocols, summaries, and reports, including documents submitted directly to pharmaceutical regulatory agencies.
Draft and update QC Standard Operating Procedures (SOPs).
Act as a technical subject matter expert (SME) and provide training and support to other analysts.
Evaluate analytical and microbiological results against defined acceptance criteria.
Conduct and document laboratory investigations through to completion.
Maintain the laboratory in a constant state of audit and inspection readiness.
Interact directly with regulatory agency inspectors during audits and inspections.
Interface with other functions including Manufacturing, Quality Assurance, Facilities, and external contractors as needed.
Other duties as assigned.
Desirable Skills and Attributes
Excellent written and verbal communication skills.
Strong customer focus with personal accountability for speed, quality, and accuracy of delivery.
Self‑motivated to work under pressure in a fast‑paced environment.
Team oriented with active participation in continuous improvement, standard work, and 5S.
Demonstrated success in achieving goals as part of a high‑performing team in a growing organization.
Proven adaptability and flexibility to support an evolving operational environment.
Education and Experience
BSc in a scientific or engineering discipline with 5+ years of cGMP laboratory experience.
Or MSc with 3+ years of cGMP laboratory experience.
Shift pattern: 4‑cycle shift.
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