Engineer I QA

Quality Assurance Specialist

This role supports our Cell Culture Media and Oligo Manufacturing processes. Responsible for review and verification of all documentation related to finished good products and independently working to resolve any inconsistencies or problems with quality or compliance issues for these as they arise. Also responsible for supporting where required daily activities of Core QA department.

Essential Functions:

• Maintain working knowledge of Regulatory and Quality System requirements (ISO13485/FDA CFR).
• Fully competent in all areas of Finish Goods release process
• Utilise problem-solving skills related to quality issues ensuring timely resolution for minimal impact.
• Prepare new documentation and edit/delete revised Standard Operating Procedures, Work instructions, Forms, etc.
• Responsible for continual monitoring of Finished Good Holds and Fails and independently deciding disposition.
• Utilise Trackwise system – non conformances, deviations, CAPA
• Provide training and support to other QA staff as required as well as other departments within operations.
• Participate in customer audits, attend technical visits and fully support and engage in customer calls
• Embrace site PPI initiatives and ensure all team members embrace this methodology
• Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems. Identify and implement opportunities for improvement across the operational function.
• Participate in personal development to further enhance skills and knowledge relevant to the position.
• Deputies in Team Supervisor's absence.
• Appropriate PPE must be worn and used in accordance with the instructions provided to them.
• May be required to perform other related duties as the need arises and/or assigned.

Education:

Bachelors/Master's degree in Chemistry, Microbiology, Engineering or related subject area preferable.

Experience:

Requires a minimum of five year's QA/QC experience in a relevant environment. Knowledge of computer applications and current software (Word/ Excel) is essential.

Strong oral and written communication skills with a demonstrated ability to work in a multi-functional team environment and to effectively harmonise with all levels in the company. Effective communication skills and the ability to collaborate with internal and external development team members are essential.

Must be a self-starter who can take general concepts and direction and produce desirable results. Also must function effectively and efficiently in a global, multi-site organization.

Contacts:

Will liaise extensively with all other departments on matters relating to quality and service in order to uphold the Company's commitment to Customer satisfaction. This involves working with people at all levels within the organisation as well as external customers and regulatory bodies.

Working Conditions:

Works in an office/lab environment but may be required to spend some time in manufacturing and the warehouse. Must be able to work overtime to complete daily tasks if required.