Devens,
MA
01434
US
Posted: 09/15/2023
2023-09-15
2023-10-31
Job Number: 24995875
Job Description
QA PRODUCT DISPOSITION SPECIALIST
DEVENS, MA
Hybrid- 50% Onsite/Remote
0-2 years of directly relevant experience in a regulated cGMP environment.
The pay ranges between $60.13 - $63.09 per hour.
Required Skills:
- B.S., in science, engineering, biochemistry, related discipline, or its equivalent
- Any combination of education, experience, and military service in line with recommendations above will be considered.
- Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, related discipline, or its equivalent.
- Previous work/academic experience where attention to detail and personal accountability were critical to success.
- Strong communication skills and the ability to follow written and verbal instructions.
- Prior evidence of successful participation in work teams where combined contribution, collaboration, and results were expected.
- Knowledge of electronic systems including any of the following preferred: SAP, Veeva, LIMS/Celabs, Infinity, and electronic batch recording.
Project Description:
- The Quality Assurance Product Disposition Specialist is responsible for supporting quality and disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with the Client's policies, standards, procedures and Global cGMP.
- The role will aid in the routine and timely release of drug products in the Cell Therapy Facility and assure the quality of manufactured products is in compliance with all applicable regulations and guidelines.
- Functional responsibilities include preparing deliverables for product release within the inventory management system (SAP).
- Prepares documentation and deliverables per Standard Operating Procedures required for drug product disposition.
- Works in electronic systems such as SAP, Learning Management, and Document Management systems.
- Verify accuracy and acceptability of drug product documentation, such as Certificate of Analysis or deviation reports, to support drug product lot disposition.
- Perform the review of batch genealogy for all raw materials and components used in each batch to ensure that they are approved and released.
- Works in electronic systems such as SAP, Learning Management, and Document Management systems.
- Works on assignments of simple to moderate complexity where some judgment is required in resolving problems and making routine recommendations.
- May contribute to drafting, reviewing, or approving procedural documents.
- Other duties as required.
Working Conditions:
- Work is performed in a typical office environment, with standard office equipment available and used.
- Work is generally performed seated but may require standing and walking for up to 10% of the time.
- Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Loren: loren@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-01538
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
#LI-LG1
Share This Job:
Login to save this search and get notified of similar positions.
