Quality Assurance Associate
|Reports To||Quality Assurance Specialist |
The Quality Assurance (QA) Associate will report directly to the QA Specialist and is responsible for supporting the Quality Management System by ensuring compliance with established procedures and quality/business requirements and supporting manufacturing operations.
|Duties & Responsibilities|
- Document Management – e.g. – Batch Records, Labels, Supporting Documentation
- Engaged with production, demonstrating strong process knowledge to issue & audit batch records, labels & supporting documentation per schedule & approved procedures
- Control and issue batch records and labels in accordance with procedures
- Change Control Process
- Support Change Controls for SOPs, forms, & process, engaging with Product Manager. Manage appropriate approvals, review for applicability, maintain logs, and support closure of change control. Participate in change control committee
- Supporting the logging, tracking, & closing out of deviations. Participate in root cause analysis and corrective action development as needed
- Document Archive/Management
- Ensure controlled documents are correctly filed, archived, & maintained in accordance with ISO and GMP requirements
- CAPA (Corrective and Preventative) Management
- Maintain CAPA Log including customer’s complaints
- Work with department managers/assigned parties to write action plans when needed
- Support review of root causes and plans, evidence, verification of effectiveness.
- Review trends and communicate concerns
- Quality Management Inputs
- Participate and support site on quality audits
- Support Quality Agreement Process with Customer, Legal and Quality
- Internal Auditor
- Where required, support Internal Audit programme
- Quality Management Inputs:
- Participate and provide feedback at Quality management review.
|Skills & Qualifications|
- Experience: 2-5 years in a regulated environment
- Knowledge of GMP manufacturing processes an advantage
- ISO 9001 and cGMP experience preferred
- Proficient in Excel and Word
- Strong communication and interpersonal skills
- Proven work experience and qualifications as a collaborative and agile team member
- Strong organization and time-management skills
- Ability to thrive in a fast-paced environment
- Attention to detail is a must.
- Possesses Company values of honesty, integrity, respect, commitment and open to change while modelling the Company Core Principles in all activities
- Ability to foster collaborative, cross department relationships to meet common objectives.