Job Description

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Quality Assurance Officer

Advertiser: Maverick Biosciences Pty LtdMore jobs from this company

Job Information

Job Listing Date
4 May 2018
Location
Dubbo & Central NSW
Work Type
Full Time
Classification
Manufacturing, Transport & Logistics, Quality Assurance & Control

Quality Assurance Officer

Maverick Biomaterials helps to save lives by producing innovative biological materials for the global human healthcare sector.

Do you want to work in a business that prides itself on having a learning organisational culture?

Are you passionate about working with operational teams to solve complex problems?

Are you looking for an opportunity to really make a difference?

Then this role will be a breath of fresh air, because at Maverick we are continually investing time to improve our processes, and need your quality manufacturing experience in the Quality team. This position offers:

  • A clean and cohesive working environment
  • Competitive salary
  • Training and development opportunities
  • Newly constructed world class facilities

Reporting to the Quality Assurance Manager, the key responsibilities will include performing functions towards maintenance of the company’s ISO 13485:2016 certification.

Key Responsibilities:

  • Updating the Quality Management System (QMS) and related documentation
  • Assisting the Quality Assurance Manager in ensuring the maintenance, continual improvement and effectiveness of the QMS
  • Participate in CAPA management as required
  • Provide support during management review meetings as required
  • Provide support during all external audits
  • Perform cleanroom monitoring as required
  • Perform some analytical testing as required including: bioburden testing, chemical analysis
  • Participate in developing SOPs and training courses as required
  • Perform site inductions as requested
  • Training of staff in company procedures relating to the QMS
  • Performing equipment calibration
  • Participating in and performing internal audits
  • Support validation activities as required
  • Maintenance of approved supplier list

Skills and Education Requirements:

We would like to hear from applicants with

  • QA/QC experience within medical device or pharmaceutical industries
  • Experience working with ISO 13485 (medical device) and/or cGMP or similar regulatory compliance environments; preferred
  • Tertiary qualifications in science; desired but not essential
  • High degree of computer literacy, primarily Microsoft Office
  • Excellent attention to detail
  • Internal auditing experience; certification desired but not essential
  • Strong organisational and time management skills
  • Excellent verbal and written communication skills
  • Strong team culture with a focus on quality

If you believe you are the right person for this position, please apply through Seek.  For a confidential discussion regarding this role, please contact Ben Rogers, Chief Operating Officer on 0423…show number.

Maverick Biomaterials helps to save lives by producing innovative biological materials for the global human healthcare sector.

Do you want to work in a business that prides itself on having a learning organisational culture?

Are you passionate about working with operational teams to solve complex problems?

Are you looking for an opportunity to really make a difference?

Then this role will be a breath of fresh air, because at Maverick we are continually investing time to improve our processes, and need your quality manufacturing experience in the Quality team. This position offers:

  • A clean and cohesive working environment
  • Competitive salary
  • Training and development opportunities
  • Newly constructed world class facilities

Reporting to the Quality Assurance Manager, the key responsibilities will include performing functions towards maintenance of the company’s ISO 13485:2016 certification.

Key Responsibilities:

  • Updating the Quality Management System (QMS) and related documentation
  • Assisting the Quality Assurance Manager in ensuring the maintenance, continual improvement and effectiveness of the QMS
  • Participate in CAPA management as required
  • Provide support during management review meetings as required
  • Provide support during all external audits
  • Perform cleanroom monitoring as required
  • Perform some analytical testing as required including: bioburden testing, chemical analysis
  • Participate in developing SOPs and training courses as required
  • Perform site inductions as requested
  • Training of staff in company procedures relating to the QMS
  • Performing equipment calibration
  • Participating in and performing internal audits
  • Support validation activities as required
  • Maintenance of approved supplier list

Skills and Education Requirements:

We would like to hear from applicants with

  • QA/QC experience within medical device or pharmaceutical industries
  • Experience working with ISO 13485 (medical device) and/or cGMP or similar regulatory compliance environments; preferred
  • Tertiary qualifications in science; desired but not essential
  • High degree of computer literacy, primarily Microsoft Office
  • Excellent attention to detail
  • Internal auditing experience; certification desired but not essential
  • Strong organisational and time management skills
  • Excellent verbal and written communication skills
  • Strong team culture with a focus on quality

If you believe you are the right person for this position, please apply through Seek.  For a confidential discussion regarding this role, please contact Ben Rogers, Chief Operating Officer on 0423…show number.

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