REGISTRIEREN

Jobbörse

Finde Jobs in deiner Nähe – ob vor Ort, hybrid oder remote.
  • Ähnliche Jobs zu: QA Operations Specialist
XX
Senior QA Specialist - OperationsLonza Group Ltd. • Portsmouth, Virginia, United States
Jetzt Bewerben
XX

Senior QA Specialist - Operations

Lonza Group Ltd.
  • US
    Portsmouth, Virginia, United States
  • US
    Portsmouth, Virginia, United States
Jetzt Bewerben

Über

Location Senior QA Specialist - Operations. This position is based in our Portsmouth, NH office. The standard schedule is a 10-hour first shift, Wednesday through Saturday, with working hours from 7:00 AM to 5:30 PM EST. Benefits Performance-related bonus. Medical, dental and vision insurance. 401(k) matching plan. Life insurance, as well as short-term and long-term disability insurance. Employee assistance programs. Paid time off (PTO). Responsibilities Perform independent review and closure of manufacturing batch records and associated documentation to support product release. Identify and assess discrepancies, non-conformances, and documentation issues, ensuring appropriate resolution in accordance with GMP requirements. Participate in lot release meetings and coordinate documentation readiness to meet release timelines. Apply knowledge of manufacturing processes and quality systems to support investigation and resolution of complex issues. Guide and support junior QA staff on documentation review priorities and decision-making. Ensure all deviations and quality events are appropriately documented, investigated, and closed. Apply data integrity principles in all aspects of work, ensuring compliance with regulatory and company standards. Contribute to continuous improvement initiatives and support daily quality operations as needed. Qualifications Bachelor’s degree in a life sciences discipline or equivalent experience. 5–10 years of experience in a cGMP-regulated environment within biotechnology or pharmaceutical manufacturing. Strong understanding of GMP regulations (e.g., ICH, FDA) and good documentation practices. Experience reviewing batch records, lot release documentation, and quality systems processes. Familiarity with systems such as TrackWise, SAP, or similar quality management systems preferred. Strong attention to detail and critical thinking skills, with the ability to identify and resolve issues effectively. Excellent written and verbal communication skills, with the ability to clearly present information and collaborate across teams. Ability to manage multiple priorities, adapt to changing workloads, and elevate issues appropriately when needed. EEO Statement At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.
#J-18808-Ljbffr
  • Portsmouth, Virginia, United States

Sprachkenntnisse

  • English
Hinweis für Nutzer

Dieses Stellenangebot stammt von einer Partnerplattform von TieTalent. Klick auf „Jetzt Bewerben”, um deine Bewerbung direkt auf deren Website einzureichen.