Qc Officer

Current Opportunity

SERB Specialty Pharmaceuticals is a global specialty pharmaceutical group focused on prescription medicines which address rare and life-threatening diseases.

Following strategic acquisitions and targeted developments, SERB has succeeded in establishing a consistent drugs portfolio focused on niche specialty pharmaceuticals to ensure continuous availability of life-saving medicines and answer unmet medical needs.

Our commitment is to continue to offer essential drugs meeting Public health needs.

The responsibility of the QC officer is to perform routine test procedures and supporting tasks within QC to ensure the timely generation of valid test results for the purpose of controlled product manufacture. Train staff as required for the smooth operation of the production process.

Principle Responsibilities

Support the production of low bio-burden serum from the blood harvested in the Sheep Production Facilities by:
Analysing serum samples according to written, validated procedures

Primary assays include but are not limited to Bioburden, Endotoxin, Biacore assays and Polarisation Fluroimmunoassay.

Involvement in Environment Monitoring Program for the manufacturing areas within the serum production facility at Turretfield.

Monitor antibody production in sheep using appropriate assays

Maintain a database of results and trend data as required

Participate in development of new methods required for the purposes of routine testing of low bioburden ovine serum, antibody and health monitoring of production flocks and qualification of new sheep for production status

Assist in the transfer of any new assays from external sources or from the BTG UK site

Validate assays for the purpose of routine testing

Ensure all quarantined incoming goods are assessed for release against a written specification.

Write and review SOPs, Work Instructions, Laboratory Methods, Specifications and AQR’s as required to ensure procedures are documented and all documents are accurate and complete.

Ensure all equipment is calibrated and maintained in accordance with written procedures

Draft calibration documents for new equipment as required

Report, Investigate and document Out of Specification results as per written procedures

Document all incidents etc. as required and ensure corrective actions are completed in a timely manner

Must comply with all relevant Workplace Health & Safety legislation, codes of practice, standards, policies, operating procedures and work instructions, and be accountable for all EHS actions.

The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

Education and Experience

An educational background in Biological / Analytical Science is required (i.e. Microbiology, Biotechnology, Chemistry, Biochemistry, and Immunology).

Previous experience in a Quality Control laboratory is preferred but not essential

Ability to prioritise workload to meet deadlines within tight timeframes with mínimal supervision;
Literacy, numeracy and proficient IT skills particularly in Excel and Word.

Skills and Attributes

Confident with the ability to work with employees at all levels of seniority utilising excellent communication skills, both on an internal and external basis.

Competent, methodical, highly organised individual who pays strict attention to detail and has the ability to effectively prioritise and execute tasks accurately within a high-pressure environment. Organisational skills should be strong with an ability to plan ahead.

Creative thinker able to solve problems, question the status quo and consider innovative solutions to complex issues.

Must be able to work as part of a team and demonstrate initiative when required with a flexible and willing attitude at all times.

Strong written and oral communication skills.

Highly self-motivated and directed.

What you will get in return

5 weeks annual leave

Extra 3 days Xmas Leave

Company Bonus scheme

Super salary sacrifice options

Salary packaging opportunities

If you are looking to align yourself with a global leader that is committed to its employees, you value team success and want to achieve significant results then BTG is the place for you.

**How to apply**: If you are looking to align yourself with a global leader that is committed to its employees, you value team success and want to achieve significant results then BTG is the place for you. The role above is complemented by a remarkable work location in the Barossa Valley.

S erb Specialty Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.