Quality Assurance Specialist I
2 weeks ago
Quality Assurance Specialist I
At Minaris Regenerative Medicine, we are committed to pioneering advancements in cell and gene therapy. As a prominent global contract development and manufacturing organization, we focus on the transformative potential of regenerative medicine, shaping the future of healthcare.
The Quality Assurance Specialist plays a crucial role in ensuring that all quality assurance processes are executed effectively and accurately. Under direct supervision, the specialist assists with essential daily tasks that are vital for maintaining and enhancing quality systems while adhering to specific client protocols.
Key Responsibilities:
- Ensure compliance with cGMP standards across all clinical and commercial manufacturing activities.
- Issue batch records and other controlled documents as required.
- Review manufacturing batch records and associated quality control data (including bioassays, raw material testing, and microbiology).
- Draft, review, and maintain cGMP documentation for Quality System Functions (such as SOPs and Work Instructions).
- Consistently follow Standard Operating Procedures and cGMP regulations.
- Maintain comprehensive cGMP documentation, including logbooks and training records.
- Assist the Manager in prioritizing, scheduling, and managing multiple projects and resources concurrently.
- Initiate quality events such as deviations, CAPAs, and Change Controls as necessary.
- Provide on-the-floor quality assurance support.
- Conduct quality assurance walkthroughs.
- Perform additional duties as assigned by management based on business needs.
Qualifications:
- Bachelor's degree in a relevant scientific discipline.
- A minimum of one year of experience in a biologics or biotechnology environment.
- Familiarity with the aseptic manufacturing processes of biologics is preferred.
- Understanding of cGMP regulations.
Candidate Profile:
- Proficient in relevant computer applications (Microsoft Office, Outlook).
- Detail-oriented with strong organizational skills.
- Possess analytical and problem-solving abilities.
- Effective written and verbal communication skills.
- Able to manage multiple tasks and adapt to changing priorities.
- Flexible and responsive to company growth and evolving responsibilities.
- Capable of working independently as well as collaboratively within a team.
Quality Commitment:
Integrate quality into every aspect of your work by ensuring compliance with all quality standards and regulations.
Participate in all required quality and compliance training as scheduled.
Working Environment:
This role requires collaboration in a team-oriented setting and may involve working during weekends and holidays as needed. Employees may encounter infectious diseases and must use appropriate personal protective equipment when handling human specimens and hazardous materials.
Physical Requirements:
This position is primarily sedentary, with occasional lifting of up to 30 pounds. Employees must be able to gown for cleanroom access and perform tasks that require mobility, including sitting, standing, and using hands for various office equipment.
Disclaimer:
The information provided in this description is intended to outline the general nature and level of work performed. It is not a comprehensive inventory of all duties, responsibilities, and qualifications required for this position. Responsibilities may change at any time with or without notice.
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