GMP Quality Officer – Pharma & Biotech

BioCell Corporation; Ōtara-Papatoetoe; On-site; NZD 70,000 - 110,000; Full time

Job summary

BioCell Corporation in Papatoetoe, Auckland, NZ is seeking an experienced Quality Officer to join our GMP manufacturing facility. The role spans QA and QC activities within a multidisciplinary team and reports to the Quality Manager.

Key responsibilities include reviewing batch records, handling deviations and CAPAs, performing risk assessments, supporting internal audits, and maintaining GMP documentation. A tertiary science qualification and strong attention to detail are required.

Qualifications

• 5+ years in QA, QC, GMP manufacturing or related quality role in pharma/biotech.
• Sound GMP knowledge and quality systems understanding.
• Experience with deviations, CAPAs, investigations and controlled docs.

Responsibilities

• Review batch manufacturing records and support QA release activities.
• Raise and investigate deviations, CAPAs and quality events.
• Perform risk assessments and support continuous improvement.
• Participate in internal audit programme.
• Prepare, review and issue SOPs and quality documents.
• Review incoming materials and related documentation.
• Prepare and review raw material and finished product specs.
• Perform QC testing per procedures.
• Support validation and qualification activities.
• Provide quality guidance to production and labs.
• Maintain GMP documentation and records.

Skills

QA experience

GMP manufacturing

CAPA investigations

Deviations handling

Risk assessments

Documentation control

QC testing

SOP development

MS Word & Excel

Education

BSc in Microbiology / Chemistry / Biochemistry / Biotechnology

Tools

MS Word

MS Excel

Job description

BioCell Corporation in Papatoetoe, Auckland, NZ is seeking an experienced Quality Officer to join our GMP manufacturing facility. The role spans QA and QC activities within a multidisciplinary team and reports to the Quality Manager.

Key responsibilities include reviewing batch records, handling deviations and CAPAs, performing risk assessments, supporting internal audits, and maintaining GMP documentation. A tertiary science qualification and strong attention to detail are required.