Manufacturing Quality Assurance Specialist

2 weeks ago

Cambridge, Massachusetts, United States The Accuro Group Full time

Position Title:
| Manufacturing Quality Assurance Specialist

Location:
Remote

Job Type:
Contract (12 Months)

Note:
Parking expenses are not covered by the organization.

Important:
A background in manufacturing is essential.

Position Overview:


The Accuro Group is a leading biopharmaceutical organization dedicated to advancing science, technology, and talent to combat diseases effectively. Our mission is to enhance the health of billions globally while ensuring sustainable returns for our stakeholders.

Our vision includes not only treating diseases but also preventing them, with a goal to positively influence the health of 2.5 billion individuals worldwide in the next decade.

We are currently seeking a skilled Quality Assurance Specialist to join our Manufacturing Compliance team. This role is pivotal in achieving departmental objectives and enhancing compliance within our manufacturing processes.

The Quality Assurance Specialist will take charge of driving improvements in manufacturing compliance through effective resolution of deviations, comprehensive root cause analysis, and the application of Corrective and Preventive Actions (CAPA) to enhance safety, quality, cost efficiency, timely delivery, and first-time quality performance.

The Specialist will collaborate cross-functionally with various internal departments to ensure successful implementation of improvements.

Key Responsibilities:

1. Lead investigations into events to accurately determine root causes and implement suitable corrective and preventive measures to avert recurrence.
2. Manage CAPA investigations and oversee the execution of corrective actions when necessary.
3. Oversee manufacturing-related change controls.
4. Organize data and prepare relevant documentation, including presentation materials for assigned projects.
5. Suggest enhancements to batch records and Standard Operating Procedures (SOPs) to minimize or eliminate Good Distribution Practice (GDP) errors or rectify root causes of deviations.
6. Review production documentation and conduct quality assessments during manufacturing operations.
7. Engage in continuous improvement initiatives such as 5S, Gemba, and The Accuro Group Production Systems (GPS).
8. Provide training and support to team members on compliance-related topics to foster a culture of compliance throughout the organization.
9. Facilitate team meetings and coordinate discussions across multiple departments.

Required Skills & Experience:

- Bachelor's degree in a relevant discipline
- Minimum of 3 years of related experience
- Proven knowledge of current Good Manufacturing Practices (cGMP) with expertise in downstream processing utilizing single-use technology (SUT)
- Familiarity with standard troubleshooting methodologies (problem statements, root cause analysis, Ishikawa diagrams, 5 Whys)
- Proficient in computer applications, particularly Microsoft Office Suite – Word, Excel, PowerPoint

Preferred Qualifications:


- Subject Matter Expert (SME) or experienced with various process equipment including homogenizers, tangential flow filtration (TFF), ultrafiltration/diafiltration (UFDF), and buffer preparation and filtration.
- Experience with regulatory agency interactions and inspection processes.
- Advanced proficiency with business software (e.g., Excel, Visio) and industry systems (LIMS, ERP, SAP).

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