QC Sample Coordinator II

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 55,000 - 82,000; Full time

Job summary

PCI TRGR Penn Pharmaceutical Services Ltd. in Bedford, NH is seeking a QC Sample Coordinator II to support the QC Sample Management group.

Responsibilities include sample receipt (in-process, finished product, raw materials, validation and client samples), coordination with external labs, aseptic sampling, and review of specifications and documentation to ensure cGMP compliance. The role requires attention to detail, ability to multi-task in a fast-paced environment, and effective communication

Qualifications

• 2-4 years relevant business experience or education.
• High school diploma required; Associate/Bachelor’s degree in a scientific discipline preferred.
• Proficient in MS Office; must have strong attention to detail and the ability to work in a cross-functional team.

Skills

Attention to detail

Cross-functional teamwork

Strong written and oral communication

Multi-tasking

Education

High school diploma

Associate's or Bachelor's degree in a scientific discipline

Tools

MS Office

Master Control

Document management system

Job description

## QC Sample Coordinator IIApply: Bedford, NH, USA: Full time: Posted Today: JR119610Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.**We are PCI.**Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.**Position Title**: QC Sample Coordinator II**Location:** Bedford, New Hampshire**Department:** Quality Control / Incoming materials**Reporting To:** QC Supervisor, Sample Management**Responsible For (Staff):** NoThis 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.**ESSENTIAL DUTIES AND 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.**QUALIFICATIONS:****Required:*** 2-4 years relevant business experience or education* High school diploma required; Associate’s or Bachelor’s degree in a scientific discipline (Biology, Chemistry, Microbiology, or related field) preferred.* 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* 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**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#LI-RS1