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Position Title: QC Sample Coordinator II

Location: Bedford, New Hampshire

Department: Quality Control / Incoming materials

Reporting To: QC Supervisor, Sample Management

Responsible For (Staff): No

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.

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

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.