QA Specialist Job Description Template
Our company is looking for a QA Specialist to join our team.
Responsibilities:
- Recommend systems for audit, write audit plans, coordinate scheduling & closure of internal audits;
- Maintain current awareness of all required standards, laws & guidelines;
- Support the processes in place to ensure customer complaints are appropriately raised and handled;
- Prepare for, carrying out, report and follow up of Quality Assurance required audits – including internal, 3rd party and vendor audits;
- Support the promotion and compliance with regulations, guidelines, and Standard Operating Procedures within the organization;
- Participate in Lean/Six Sigma, process improvements;
- Provide oversight & participate in review root cause analysis, corrective action & preventive action plans for Quality Issues & customer complaints;
- Support the processes in place to ensure internally identified Quality Issues are appropriately raised and handled;
- Participate in review of root cause analysis, corrective action & preventive action plans for internal, 3rd party & vendor audits;
- Provide oversight to the documentation, reporting, effectiveness checks & closure of compliance issues (audits, Quality Issues & customer complaints);
- QA Review of GMP Production & Lab documents;
- CAPA Authoring;
- QA Approval;
- Review of executed Batch Records;
- Perseverance in investigations of non-conformances to ensure true root cause is derived and effective corrective actions are implemented.
Requirements:
- Knowledge of and demonstrated experience in Good Clinical Practice (GCP), ISO15189, NEQAS, CAP, CLIA strongly preferred;
- 3 years of quality assurance experience required; experience in a laboratory, pharmaceutical or Clinical Research Organization (CRO) preferred;
- Bachelor’s degree or at least 10 years of Quality Assurance experience in the healthcare industry required;
- BS/BA degree and a minimum of 2-3 years of relevant experience;
- Must have an understanding and application of QA principles, concepts, industry practices, and standards;
- Strong verbal, technical writing, time management and interpersonal skills are required;
- Must have strong writing skills to present findings in a clear and concise manner;
- Normally receives no instruction on routine work, general instructions on new assignments;
- Must have a desire to demonstrate excellence by setting high standards;
- Interfaces with contract manufacturers and suppliers to address documentation and compliance issues;
- May conduct or serve as lead/coordinator of investigations and corrective action (CAPA) recommendations related to manufactured products;
- Performs a variety of activities to ensure compliance with applicable regulatory requirements;
- Experience in a Quality Unit role (1-3 years);
- Some experience using Statistical Process Control;
- Need to pass the American Society of Quality (ASQ) Lead Auditor Certification or equivalent.