QA Specialist I - Collins Consulting Inc
Worcester, MA 01605
About the Job
This is an onsite position. Looking for local candidates only.
The Quality Associate supports the Quality Function that they are responsible for within Operations. This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance. Expectations that the Quality Associate will maintain high quality levels on all aspects of their job while achieving high levels of efficiency.
Responsibilities :
Qualifications :
Years of experience/education and/or certifications required:
What are the top 3-5 skills requirements should this person have?
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
The Quality Associate supports the Quality Function that they are responsible for within Operations. This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance. Expectations that the Quality Associate will maintain high quality levels on all aspects of their job while achieving high levels of efficiency.
Responsibilities :
- Responsible for various aspects of quality assurance and quality control related to their functional area.
- Ensures that product within the plant is consistently manufactured in conformance with company Quality System requirements and all applicable regulatory requirements.
- Support troubleshooting and resolution of quality compliance issues.
- Communicates with Management for Quality Management Review, Quality Initiatives, etc.
- Incumbent is responsible for quality decisions related to their functional area to ensure compliance with company Quality Systems and cGMPs.
Qualifications :
- Must be familiar with use of electronic document management and laboratory information management.
- Must also be familiar with Quality Systems as well as cGMP and other regulatory requirements.
- Strong communication skills, both oral and written
Years of experience/education and/or certifications required:
- Bachelor s Degree/ 2+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry
What are the top 3-5 skills requirements should this person have?
- Whether it is through manufacturing or quality control, a certain level of quality experience is necessary.
- Some form of review experience: data or record review
- 1+ years within a manufacturing facility
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
- Bonus: some work with investigations
- Bonus: experience with document revisions
- Bonus: review of GMP commercial batch records
Source : Collins Consulting Inc
