Talent.com
Specialist II, Quality Assurance – Lot Review
Specialist II, Quality Assurance – Lot ReviewLonza • Queenstown, Otago, New Zealand
Specialist II, Quality Assurance – Lot Review

Specialist II, Quality Assurance – Lot Review

Lonza • Queenstown, Otago, New Zealand
2 days ago
Job description

Specialist II, Quality Assurance – Lot Review

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

As a QA specialist you will provide day-to-day Quality Assurance activities support in accordance with approved SOPs / Policies for a large-scale GMP Biotech Manufacturing facility.

Join our best-in-class high-performance Integrated Biologics team at our Tuas site in Singapore to gain unparalleled exposure to cutting‑edge biotechnology and innovation. Learn new skills and capabilities. Grow your career with us in manufacturing therapeutic proteins under cGMP conditions. Find out more about what a life at Lonza in Singapore could look like for you by watching this short video.

What you’ll get

  • An agile career and dynamic working culture in a global life sciences leader.
  • An inclusive and ethical workplace that values diversity and integrity.
  • Competitive compensation programs that recognize high performance.
  • Professional growth opportunities through cross‑functional projects and global exposure.
  • Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums.
  • Company transport provided from designated MRT locations to and from the Tuas site.
  • Access to Lonza’s full suite of employee benefits :

What you’ll do

  • Support day‑to‑day QA activities in compliance with SOPs / policies in a multi‑product, GxP contract manufacturing facility.
  • Ensure process awareness, identifying operational factors affecting the process.
  • Review and approve SOPs, protocols, reports, and records.
  • Troubleshoot issues, weighing all information to determine optimal solutions.
  • Lead small projects and manage deliverables effectively.
  • Build strong working relationships with internal and external customers.
  • Plan and coordinate future activities with other departments.
  • Develop into a qualified trainer in the area of expertise.
  • Review batch records, raise deviations, and compile lot genealogy.
  • Escalate process events based on SOPs / policies.
  • Support changeover activities and provide oversight for document changes.
  • Detect non‑compliance with cGMP / GDP, provide corrective guidance.
  • Participate in walkdowns, audits, and provide feedback for improvement.
  • Lead or participate in deviation investigations, change controls, and CAPA plans.
  • What we’re looking for

  • Degree from a recognized institution with 3 to 5 years’ experience in a similar type of industry or a similar job role.
  • Diploma with 5–7 years’ experience in a similar type of industry or a similar job role.
  • Familiarity with regulatory requirements and local codes & standards (e.g., FDA, EMEA, and ICHQ7).
  • Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
  • Meticulous and systematic, team player, with strong focus on safety, quality and timelines.
  • Able to operate independently with minimum supervision.
  • Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

    People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

    #J-18808-Ljbffr

    Create a job alert for this search

    Assurance Specialist • Queenstown, Otago, New Zealand

    Related jobs
    Senior Qa Validation Specialist (Pharmaceutical Manufacturing)

    Senior Qa Validation Specialist (Pharmaceutical Manufacturing)

    Jobstreet Sg • Queenstown, Otago, New Zealand
    Senior QA Validation Specialist (Pharmaceutical Manufacturing).The QA Validation Engineer will play a vital role in establishing and maintaining high-quality standards at a growing pharmaceutical m...Show more
    Last updated: 30+ days ago • Promoted
    Quality Assurance Leader : QMS & ISO Expert

    Quality Assurance Leader : QMS & ISO Expert

    Hegen Pte. Ltd. • Queenstown, Otago, New Zealand
    A leading mother and baby products company is seeking a highly experienced Quality Assurance Manager to oversee quality assurance strategies across operations. The successful candidate will implemen...Show more
    Last updated: 7 days ago • Promoted
    Laboratory Tech | 1-Year Contract #HTJ

    Laboratory Tech | 1-Year Contract #HTJ

    Recruit Express • Queenstown, Otago, New Zealand
    Location : Biopolis (Walkable from Buona Vista).Completing and reviewing work assignments and adjusting workload and resources periodically with the team. Mentoring and cross‑training staff with a st...Show more
    Last updated: 10 hours ago • Promoted • New!
    •URGENT • Food Tech / QA / QC / Lab Analyst - (Min Dip / Deg) #HFT

    •URGENT • Food Tech / QA / QC / Lab Analyst - (Min Dip / Deg) #HFT

    Recruit Express • Queenstown, Otago, New Zealand
    URGENT • Food Tech / QA / QC / Lab Analyst - (Min Dip / Deg) #HFT.Perform analytical and testing accurately and in accordance to Standard Operating Procedures (SOPs). Document all results in accordance...Show more
    Last updated: 20 days ago • Promoted
    Associate (Quality Assurance) (cloned)

    Associate (Quality Assurance) (cloned)

    NTUC Foodfare • Queenstown, Otago, New Zealand
    Travel to our central kitchens to perform regular inspections, ensuring all food handling and cooking activities comply with our Pre‑Requisite Programs (PRPs) and Critical Control Points (CCPs).Foo...Show more
    Last updated: 30+ days ago • Promoted
    Quality And Regulatory Affairs Specialist

    Quality And Regulatory Affairs Specialist

    Majeton • Queenstown, Otago, New Zealand
    Quality and Regulatory Affairs SpecialistAt Majeton,weare driven by our commitment to deliver "The Right Product for Health". Our team of researchers and clinical experts utilize clinic feedback fro...Show more
    Last updated: 30+ days ago • Promoted
    Associate (Quality Assurance) (Cloned)

    Associate (Quality Assurance) (Cloned)

    Ntuc Foodfare • Queenstown, Otago, New Zealand
    Site inspections : Travel to our central kitchens to perform regular inspections, ensuring all food handling and cooking activities comply with our Pre-Requisite Programs (PRPs) and Critical Control...Show more
    Last updated: 30+ days ago • Promoted
    Quality and Regulatory Affairs Specialist

    Quality and Regulatory Affairs Specialist

    Majeton • Queenstown, Otago, New Zealand
    Quality and Regulatory Affairs Specialist.At Majeton,weare driven by our commitment to deliver “The Right Product for Health”. Our team of researchers and clinical experts utilize clinic feedback fr...Show more
    Last updated: 30+ days ago • Promoted
    Quality Assurance Leader : Qms & Iso Expert

    Quality Assurance Leader : Qms & Iso Expert

    Hegen Pte. Ltd. • Queenstown, Otago, New Zealand
    A leading mother and baby products company is seeking a highly experienced Quality Assurance Manager to oversee quality assurance strategies across operations. The successful candidate will implemen...Show more
    Last updated: 6 days ago • Promoted
    Maintenance Manager - Holiday Inn Queenstown Frankton Road

    Maintenance Manager - Holiday Inn Queenstown Frankton Road

    Sarin Hotels Group • Queenstown-Lakes, Otago, New Zealand
    Seeking a skilled Maintenance professional who can take the lead in carrying out facilities management activities on our hotel premises. USAR QUEENSTOWN LTD T / A HOLIDAY INN QUEENSTOWN FRANKTON ROAD....Show more
    Last updated: 25 days ago • Promoted