PCI Pharma Services
Life 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.
JOB DESCRIPTION Position Title : QC Sample Coordinator I
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, which includes use of material control procedures and specification documents, raw material sampling & inspection, participation in the coordination of testing with internal and external resources, and collection of data and material certificates for review by QA.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Ordering, receipt and management of QC Laboratory supplies, including chemicals, reference standards, and consumable materials in accordance with cGMP and procedural requirements
Inspection, review and receipt of incoming samples for testing. Verification of information against specifications, protocols, and other documentation to ensure 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.
Request, assemble, and distribute QC testing data packets for support of in-process, lot release, raw material, and stability testing
Assist with coordinating external testing
Request and maintain Quality Control logbooks in accordance with cGMP and procedural requirements
Perform inspections on packaging components
QUALIFICATIONS Required
1-3 years relevant business experience
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
Preferred
Ability to work independently as well as on a team, with limited supervisory oversight
Master Control experience a plus
cGMP experience a plus
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
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.
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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.
JOB DESCRIPTION Position Title : QC Sample Coordinator I
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, which includes use of material control procedures and specification documents, raw material sampling & inspection, participation in the coordination of testing with internal and external resources, and collection of data and material certificates for review by QA.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Ordering, receipt and management of QC Laboratory supplies, including chemicals, reference standards, and consumable materials in accordance with cGMP and procedural requirements
Inspection, review and receipt of incoming samples for testing. Verification of information against specifications, protocols, and other documentation to ensure 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.
Request, assemble, and distribute QC testing data packets for support of in-process, lot release, raw material, and stability testing
Assist with coordinating external testing
Request and maintain Quality Control logbooks in accordance with cGMP and procedural requirements
Perform inspections on packaging components
QUALIFICATIONS Required
1-3 years relevant business experience
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
Preferred
Ability to work independently as well as on a team, with limited supervisory oversight
Master Control experience a plus
cGMP experience a plus
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
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.
#J-18808-Ljbffr