What are the responsibilities and job description for the RFD_Quality Control Coordinator position at PCI Services Ltd?
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.
Quality Control Coordinator
The hiring rate for this position is $18.50/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
Summary of Objective
The Quality Assurance Coordinator is responsible for properly maintaining critical Quality Assurance Inspection systems including the PCI Non-Conforming Material Report (NMR) system and the PCI retain / customer sample programs. These systems are to be maintained in accordance with PCI, Customer and GMP requirements.
Essential Duties And Responsibilities
Properly pack for shipment daily customer samples including cold chain. Review customer standards, procedures and specifications relative to customer sample and retain requirements. Responsible for organizing and maintaining proper storage and disposal of PCI and customer retain samples. Maintain adequate inventory of cold shipment supplies. Perform annual visual inspection of retains per APR requirements. Organize and maintain NMR associated paperwork including samples and ensuring proper close out. Maintain accurate logs of all NMR's. Perform all NMR associated transactions within JDE. Coordinate with appropriate Business Unit representatives, Purchasing, Warehouse and Quality on NMR details and disposition. Maintain required Quality Metrics related to NMR's and report to Management on a routine basis. This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.
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
between 1/4 and 1/2 of the day.
This position may have the following special vision requirements.
The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
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.
Required
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.
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.
Quality Control Coordinator
The hiring rate for this position is $18.50/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
Summary of Objective
The Quality Assurance Coordinator is responsible for properly maintaining critical Quality Assurance Inspection systems including the PCI Non-Conforming Material Report (NMR) system and the PCI retain / customer sample programs. These systems are to be maintained in accordance with PCI, Customer and GMP requirements.
Essential Duties And Responsibilities
Properly pack for shipment daily customer samples including cold chain. Review customer standards, procedures and specifications relative to customer sample and retain requirements. Responsible for organizing and maintaining proper storage and disposal of PCI and customer retain samples. Maintain adequate inventory of cold shipment supplies. Perform annual visual inspection of retains per APR requirements. Organize and maintain NMR associated paperwork including samples and ensuring proper close out. Maintain accurate logs of all NMR's. Perform all NMR associated transactions within JDE. Coordinate with appropriate Business Unit representatives, Purchasing, Warehouse and Quality on NMR details and disposition. Maintain required Quality Metrics related to NMR's and report to Management on a routine basis. This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.
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
- Stationary Position: From 1/4 to 1/2 of the day.
- Move, Traverse: From 1/2 to 3/4 of the day.
- Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up.
- Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.
- Ascend/Descend or Work Atop: Up to 1/4 of the day.
- Position self (to) or Move (about or to): 3/4 of the day and up.
- Communicate or exchange information: 3/4 of the day and up.
- Detect, distinguish, or determine: From 1/2 to 3/4 of the day.
between 1/4 and 1/2 of the day.
This position may have the following special vision requirements.
- Close Vision ? Distance Vision ? Color Vision ? Peripheral Vision ? Depth Perception
- Ability to focus ? No Special Vision Requirements
The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
- Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for 1/4 to 1/2 of the day. *
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.
Required
- High School Diploma or GED and/or 1-3 months related experience and/or training.
- Basic Mathematical Skills
- Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
- Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.
- Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.
- Other Required Skills.
- Ability to demonstrate attention to detail.
- Ability to follow instructions and respond to management direction.
- Ability to work independently and/or as part of a team.
- Ability to display excellent time management skills.
- If other, please type here.
- If other, please type here.
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.
Salary : $19
