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Quality Assurance Specialist I
2 months ago
Position: 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 are dedicated to enhancing the future of medicine through innovative therapies.
Role Summary:
The Quality Assurance Specialist I will be responsible for executing Quality Assurance tasks under the direct supervision of senior staff. This role supports Quality Systems and client procedures, encompassing document management, quality control data review, material and final product releases, and assisting management with departmental needs.
Key Responsibilities:
1. Ensure compliance with internal quality standards and external regulations related to pre-clinical, clinical, and commercial manufacturing.
2. Thoroughly read, comprehend, and adhere to all cGMP and cGTP documentation relevant to Quality System Functions (SOPs, WIs, etc.).
3. Maintain compliance with cGMP and cGTP across all manufacturing stages.
4. Conduct inspections and releases of raw materials in accordance with SOPs and regulatory standards.
5. Manage batch records issuance and review media batch records.
6. Issue and maintain all cGMP and cGTP documentation, including logbooks and training materials.
7. Oversee the accessioning of incoming Apheresis.
8. Perform additional duties as assigned.
Qualifications:
- Bachelor’s degree in a related scientific field.
- Previous experience in a biologics or biotechnology setting is preferred.
- Familiarity with the aseptic manufacturing process of biologics is advantageous.
- Understanding of cGMP and cGTP regulations is essential.
Candidate Profile:
- Proficient in Microsoft Office and Visio.
- Excellent written and verbal communication skills.
- Strong presentation abilities are preferred.
- Detail-oriented with the capacity to multitask and work collaboratively in a team environment, adapting to evolving responsibilities.
Quality Commitment:
Integrate quality into every aspect of your work by adhering to all quality requirements and ensuring compliance with FDA and global Quality & Compliance regulations.
Training Requirements:
Complete the following training within the first 90 days of employment:
- GXP training
- SOP & WI training
- Safety Training
Working Environment:
Employees may encounter infectious diseases and are expected to utilize universal precautions. Additional exposures may include gases and corrosive chemicals. The work environment may be moderately noisy, and the ability to work in a team-oriented setting is essential.
Physical Requirements:
The Quality Assurance Specialist I must be capable of working in a laboratory setting for extended periods, with the physical ability to stand, walk, sit, bend, stretch, and use hands for various tasks.
Disclaimer:
This job description is intended to convey the general nature and level of work performed. It is not a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this position. Responsibilities may change at any time with or without notice.
