Quality Officer – Pharmaceutical / GMP

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 is a privately owned New Zealand biotechnology and biomanufacturing company specialising in the development and manufacture of sterile pharmaceutical products, including injectables and vaccines.

We work with a diverse range of clients including multinational companies, Crown Research Institutes and leading universities in New Zealand and internationally.

With continued growth, expansion of our manufacturing capabilities and an increasingly diverse portfolio across animal, plant and human health, we are looking for an experienced Quality Officer to join our multidisciplinary team at our manufacturing facility in Papatoetoe, Auckland.

Quality Officer – Pharmaceutical / GMP

Biocell Corporation is a privately owned New Zealand biotechnology and biomanufacturing company specialising in the development and manufacture of sterile pharmaceutical products, including injectables and vaccines.

We work with a diverse range of clients including multinational companies, Crown Research Institutes and leading universities in New Zealand and internationally.

With continued growth, expansion of our manufacturing capabilities and an increasingly diverse portfolio across animal, plant and human health, we are looking for an experienced Quality Officer to join our multidisciplinary team at our manufacturing facility in Papatoetoe, Auckland.

The opportunity

This is a permanent, full time position within our Quality Department, reporting to the Quality Manager.

The role provides exposure across both Quality Assurance and Quality Control activities and would suit an experienced quality professional who enjoys working closely with manufacturing, laboratory and technical teams in a GMP environment.

Key responsibilities will include:

• Reviewing batch manufacturing records and supporting QA release activities

• Raising and investigating deviations, CAPAs and other quality events

• Performing risk assessments and supporting continuous improvement initiatives

• Participating in the internal audit programme

• Preparing, reviewing, revising and issuing SOPs and other controlled quality documents

• Reviewing incoming materials and associated documentation

• Preparing and reviewing raw material and finished product specifications

• Performing QC testing in accordance with approved procedures

• Supporting validation and qualification activities

• Providing quality and compliance guidance to production and laboratory staff

• Maintaining accurate and complete GMP documentation and records

Skills and experience

To be successful in this role, you will have:

• At least 5 years' experience in QA, QC, GMP manufacturing/production, or a closely related quality-focused role within the pharmaceutical, biotechnology or similarly regulated industry.

• A sound working knowledge of GMP principles and quality systems

• Experience with deviations, CAPAs, investigations, risk assessments and controlled documentation

• Strong written and verbal communication skills

• Excellent attention to detail and a high standard of record keeping

• The ability to work independently while also contributing effectively within a close-knit multidisciplinary team

• The ability to manage competing priorities and meet deadlines in a fast-paced manufacturing environment

• The confidence to support and train staff in GMP, compliance and validation requirements

• Good proficiency in Microsoft Word and Excel

• A tertiary qualification in a relevant scientific discipline such as Microbiology, Chemistry, Biochemistry, Biotechnology or a related field

Previous experience working across Quality and GMP manufacturing/production environments would be highly regarded, particularly in sterile pharmaceutical manufacturing, microbiological testing or validation.

This is an opportunity to join a growing New Zealand biotechnology company and work across a varied portfolio of products and projects within an established GMP manufacturing environment.

Applications close 18th September. Only shortlisted candidates will be contacted.