QC Sample Coordinator II

PCI Pharma Services•Bedford, NH

2d•Onsite

About The Position

This position will have responsibility for supporting activities in the QC Sample Management group. The coordinator II is responsible for QC tasks supporting the laboratory group, including sample receipt of in process, final product, raw material, validation and client samples as well as management of laboratory reference standards. This position also supports work on incoming raw materials by coordinating testing with external contract laboratories and performing aseptic sampling utilizing appropriate materials and following applicable material specifications and SOPs. This position will involve reviewing internal and external specifications, validation protocols, contract laboratory reports, and final reconciliation / close out of materials prior to submission to QA for review. Additionally, this position will conduct dimensional testing of incoming containers and closure samples with the use of calibrated instrumentation to support raw material release.

Requirements

2-4 years relevant business experience or education
High school diploma required
Proficient in MS Office.
Must have strong attention to detail as well as ability to work in a cross-functional team environment
Professional interpersonal skills and the ability to communicate well orally and in writing
Ability to multi-task in a dynamic environment with changing priorities
Ability to work independently as well as on a team, with limited supervisory oversight
Experience in aseptic handling of materials

Nice To Haves

Associate’s or Bachelor’s degree in a scientific discipline (Biology, Chemistry, Microbiology, or related field) preferred.
Master Control or equivalent experience working with a validated document system preferred
Basic understanding of cGMP, GDP, and laboratory workflows preferred
Laboratory experience and familiarity with chemical handling preferred

Responsibilities

Management of the reference standard inventory, including communication with internal project management teams to request additional client supplied materials and updated documentation for materials currently in inventory.
Inspection, review and receipt of incoming samples for testing in the QC laboratory and/or contract laboratories.
Verification of information against specifications, protocols and other documentation to ensure accurate material receipt and compliance.
Maintain sample tracking and chain of custody records in accordance with cGMP and procedural requirements.
Complete data entry in validated systems and business tools with a high degree of accuracy.
Coordinating testing with external contract laboratories. Request quotes and POs as needed, and coordinate with project management for client managed testing.
Provide documentation and samples to the materials management team to process for shipment.
Review and reconcile completed testing packets prior to submission to QA Document Control for long term storage.
Request and maintain Quality Control logbooks in accordance with cGMP and procedural requirements
Perform sampling and dimensional inspections on container and closure materials.
Perform aseptic sampling on critical production materials including active ingredients, bulk drug substances, excipients.
Sample materials following the outlined instructions in specifications and SOPs ensuring that there is no impact to the bulk material or contamination of test samples.
Operate safely while handling materials including performing sampling under nitrogen overlay and in the biological safety cabinet.
Review client documentation and test results with a high degree of accuracy to ensure that materials meet all cGMP requirements for use in production.
Approve materials and test results for submission to QA for release.