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Summary:
Under general direction of the Local Quality Manager/Supervisor plays an important role supporting all quality processes for Clinical Supply Solutions and Transport divisions including quality assurance tasks and quality control checks. Provides support to transport office and Clinical Trial and Commercial storage solution associates on all matters pertaining to quality and compliance.
Responsibilities:
Quality Management System:
Quality Management System Management: To follow Quality Assurance Policies and Procedures, supporting the implementation of Quality Assurance Standards.
Assist with the preparation of local Key Performance Indicators and assist/collaborate in other tasks such as but not limited to:
Quality related processes: Collaborate with the local Quality team in all quality related processes such as change control, external/internal/certification audits, risk assessments, Quality Agreements, etc.
Supplier Qualification Management: Assist with the Suppliers Evaluation program (i.e., coordinate self-assessments responses, follow up on pending information, etc.).
Incident Management: To participate in the Corrective and Preventive Action and complaint process, including collaborating in the investigation, support with the generation of reports, and tracking deviations and actions as described on the specific internal guidelines.
Technical Quality Support: Assist with temperature mapping, calibration, maintenance, and qualification program according to internal guidelines.
Documentation Management: Support accurate documentation of all quality-related activities such as Standard Operating Procedures, work instructions, test records, audit reports, etc. Support the translation of internal guidelines and the creation/revision and control of local policies, Standard Operating Procedures, and Work Instructions.
Quality Data Management: Assist the local Quality team in maintaining all applicable documentation properly filled and up to date either electronic or paper based.
Assist in data maintenance, i.e. maintaining tracking lists and maintaining data. Execute all tasks using dedicated software tools such as Master Control and SharePoint (or other applicable software tools). This includes accurately inputting and timely updating data, attaching relevant documents, tracking progress, documenting actions taken, and adhering to any specific workflows or process as outlined in the standard operating procedures.
Pest Control and Facility Cleaning: To ensure that pest control and cleaning programs are properly implemented and documented following applicable SOPs.
Quality Control:
Compliance Assurance:
Assist in ensuring compliance with relevant regulations (local law, Gross Domestic Product, quality regulations etc), industry standards (such as International Organization for Standardization and relevant Good Practice standards), customer requirements, and internal policies.
Assist in verifying adherence of World Courier employees to all Company Policies and Procedures as applicable to their role and responsibilities.
Quality Training and Education:
Training Program: Assist in the organization of any quality related training.
Internal Guidelines Training Management:
Support and/or generate and assess training compliance reports for the local team.
Support and / or maintain local training matrix.
Process Improvement:
Continuous Improvement: To support opportunities for process improvements as initiated by the Local Quality Management.
Customer Satisfaction: To enhance the quality of service delivered to clients by closely collaborating with the operational team.
Others:
Keeping appropriate records of any delegated duties and execute tasks and responsibilities as per delegation plan or assigned to the Quality Assurance support team.
Any other quality responsibilities assigned by Local Quality Management.
Reports Directly To:
.
Education:
Bachelor's degree in life sciences, business administration, supply chain, or a related field, or equivalent experience required.
Experience:
Less than 2 years of experience in quality assurance, quality systems, or a regulated operational environment, or a related field required.
Minimum Skills, Knowledge and Ability Requirements:
Basic understanding of quality management processes and Good Practice (Good Manufacturing Practice/Good Distribution Practice) basics.
Ability to follow defined steps, use existing checklists to resolve standard problems, and escalate exceptions promptly.
Strong organizational skills and the ability to maintain traceable work artifacts (tickets, logs, files).
Effective communication skills to confirm requirements within the team and provide timely status updates.
Proficiency in Microsoft Office (Excel, Word, and PowerPoint).
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full time
Affiliated Companies: World Courier (Aust) Pty. Ltd
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
