What are the responsibilities and job description for the QC Sample Coordinator III position at 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.
Summary of Objective:
QC Sample Management is highly integrated with the operational activities of the site. A high level of proficiency and accuracy is expected of every QCSM coordinator. Primary activities include authoring and reviewing material control procedures (MCPs) and specification documents, raw material sampling, coordinating testing with internal and external resources, collation of data and certificates of analysis for review by QA. Success of the QC Sample Management team is critical to the success of the overall operations of the site.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
- Schedule and perform sampling of raw materials across the PCI NH sites and complete all applicable sample submission paperwork to the appropriate testing labs.
- Inspection, sampling and testing coordination of incoming components and raw materials, including chemicals, biologics and packaging / labeling materials in accordance with cGMP and procedural requirements
- Request, assemble, and distribute QC testing data packets for support of in-process, lot release, raw material, and stability testing
- Maintain sample tracking and chain of custody records in accordance with cGMP and procedural requirements
- Review MCP specifications and results to ensure accuracy and compliance.
- Coordinate external testing
- Perform inspections on packaging components
- Request and maintain Quality Control logbooks in accordance with cGMP and procedural requirements
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to walk and drive between local sites
- Must be able to physically wear laboratory protective attire and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
- Must be comfortable working with and handling hazardous materials in safety cabinets
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- 5 years relevant business experience
- Post high school education or work equivalent preferred
- Experience with cGMP regulated industry preferred
- Experience with QC testing laboratory or Raw Materials testing 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
- Ability to work with internal and external customers
- 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, Diversity, Equity, and Inclusion (DEI) 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.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.
