Quality Specialist / Samples Management (Pharma Manufacturing)
Our client, a world leading Pharmaceutical Company in Andover, MA is currently looking for a Quality Specialist / Samples Management (Pharma Manufacturing) to join their expanding team.
Job Title: Quality Specialist / Samples Management (Pharma Manufacturing)
Duration: 6 months contract, extendable up to 18 months
Location: Andover, MA
Client has the right–to–hire you as a permanent employee at any time during or after the end of contract.
You may participate in the company group medical insurance plan
Project Coordinator III
The primary focus of this p osition is to provide sample management and associated logistical support during a drug substance process validation campaign.
Key responsibilities include the following:
Create and maintain master sample plan by assembling sampling requirements from all applicable activities, laboratories, and stakeholders associated with the process validation campaign
Maintain and enforce sample management workflow and processes
Provide data verification and documentation support to ensure alignment of the master sample plan with GMP documentation such as protocols and batch records, and laboratory information system (LIMS)
Support ad–hoc, supplemental sample requests utilizing a paper–based or electronic sample request workflow; coordinate with sample requestor and manufacturing on ad–hoc/supplemental sample requests
Daily coordination with manufacturing to confirm that sampling plan and sampling requirements are understood and followed, where required
Periodic check–in with laboratories and sample requestor on the receipt of samples
Escalation and coordinate resolution of sampling related issues including, but not limited to, missed samples, production plan changes, and sample plan changes
Query and collate laboratory results from submitted samples; provide data verification and documentation support to summarize laboratory results in validation and technical reports.
Provide supplemental logistical, administrative, and documentation support for the preparation of, and the duration of the process validation campaign
Provide sample label generation support and coordination of label placement in the manufacturing batch records.
Must have Pharma industry experience, analytical background
lab analyst understanding of concepts – Note: this is an office–based position, not in the lab.
LIMS experience (LIMS experience is not mandatory, but strongly preferred.)
attention to detail
follow processes and procedures
SOP, CGMP environment
looking for STEM background/ degree
QC background/ understanding of testing and sample process
would like to see more details on resume of detail oriented, planning , scheduling
BS min requirement !
remote due to COVID but is regularly an onsite position. If COVID restrictions lift, worker will go onsite
Looking for people that have a GMP quality control background and have worked in a sample data management systems like LIMS or people that have a biopharma manufacturing background and is used to the regulated environment that we work in.
If they have process or method validation background that's a plus. The person should be comfortable with spreadsheets of data and should be detail oriented to track and coordinate the hundreds of samples that need to be tested and documented in various reports.
A PMP is not needed but the person should be organized and able to work with a cross functional team to complete tasks.
Seeing people with clinical trial experience which is hospital based and not manufacturing based.