Address
Form of work QA SPECIALIST
SUMMIT, NJ
SUMMIT, NJ
Hybrid Schedule: 50% Onsite
The pay ranges between $ 62.75 to $66.91 per hour.
Required Skills:
- Associate degree or bachelor's degree in biochemistry, cell biology, microbiology, chemistry, engineering or related areas, or equivalent work experience.
- 5+ years related industry experience with a minimum of 3 years' experience in quality assurance, quality control, and compliance.
- Knowledge of applicable FDA/EMA regulations in the biotechnology industry.
- Strong organizational skills, including ability to follow assignments through to completion.
- With moderate oversight from manager, think strategically and understand global impact of decisions.
- Excellent verbal and written communication skills.
- Detail-oriented with demonstrated applications in problem solving.
Preferred Skills:
- Experience within Cellular Therapeutics and/or gene-based products.
- Experience with Commercial products manufacture, supply and post-approval change management
- Experience managing external suppliers and other supply chain issues.
- Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition.
Project Description:
- The Specialist QA (CMO) position is an individual contributor role responsible for supporting Supplier Qualification activities and QA oversight of CMO viral vector manufacturing operations in accordance with business agreements and international regulatory and industry standards.
- Partner closely with Clients External Manufacturing team and the Virtual Plant Team to ensure consistent and collaborative messaging to external manufacturing partners.
- Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners.
- Effectively communicate issues, risks and proposed solutions within the organization.
- Assist with and provide QA approval of investigations, CAPAs, changes, validation documentation, and other related GMP documentation.
- Provide communication, support, and guidance to manufacturing partners and within the QA CMO team.
- Conduct reviews of CMO batch records, evaluate deviation investigations, changes and batch disposition.
- Proven ability to work effectively in a matrixed organization.
- Support internal and external audits as needed.
- Create and revise Standard Operating Procedures as needed.
- Other duties as assigned.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Margo: margo@alphaconsulting.com
ALPHA'S REQUIREMENT #23-01689
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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