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Senior Sample Coordinator - Sample Management , LIMS , GMP
Pharmaceutical Product Development (PPD)
CA-Foster City-FSP Foster City CA
Submission for the position: Senior Sample Coordinator - Sample Management , LIMS , GMP - (Job Number: 171381)
In labs and health care facilities worldwide - HERE WE ARE
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our customers through our collaborative approach, including PPD Laboratories FSP. PPD Laboratories FSP is a unique partnership that allows our customers to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.
As aSenior Logistics Coordinator, you will be responsible and accountable for the receiving, processing, storing, tracking,-shipment and delivery, return drug accountability, reconciliation and destruction of clinical samples. You will be responsible for logistics coordination of an average of around 10-15 stability studies as well as Research and Development sample inventory. This candidate will manage day to day coordination activities in absence of a Logistics Manager all while working onsite at a customer lab facility.
Additional responsibilities while working onsite at a major biopharmaceutical client site:
Coordinate sample submission workflow from receipt to disposal in LIMS
Maintain Non-GMP (Research) Sample room inventory
Ensure all materials going into the lab are appropriately labeled by conducting reviews
Coordinate, handle, verify, label, store, track, and pull Research and Development stability samples
Verify, update, and maintain Development Stability Study Setup template status reports and Outlook reminders/updates
Distribute samples to various labs
Support third party contract lab shipping of samples and receiving
Reconcile sample inventory based on criticality of samples
Ensure all work is performed /documented in a GMP compliant manner and per applicable regulatory requirements
Facilitate communication and updates to Sampling Plan documents
Route sample plans change requests, track and escalate as necessary to area management
Develop strong relationship with lab personnel.At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.
Join PPD in our relentless pursuit of excellence - apply now!
What To Expect Next
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.
In labs and health care facilities worldwide - HERE WE ARE
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our customers through our collaborative approach, including PPD Laboratories FSP. PPD Laboratories FSP is a unique partnership that allows our customers to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.
As aSenior Logistics Coordinator, you will be responsible and accountable for the receiving, processing, storing, tracking,-shipment and delivery, return drug accountability, reconciliation and destruction of clinical samples. You will be responsible for logistics coordination of an average of around 10-15 stability studies as well as Research and Development sample inventory. This candidate will manage day to day coordination activities in absence of a Logistics Manager all while working onsite at a customer lab facility.
Additional responsibilities while working onsite at a major biopharmaceutical client site:
Coordinate sample submission workflow from receipt to disposal in LIMS
Maintain Non-GMP (Research) Sample room inventory
Ensure all materials going into the lab are appropriately labeled by conducting reviews
Coordinate, handle, verify, label, store, track, and pull Research and Development stability samples
Verify, update, and maintain Development Stability Study Setup template status reports and Outlook reminders/updates
Distribute samples to various labs
Support third party contract lab shipping of samples and receiving
Reconcile sample inventory based on criticality of samples
Ensure all work is performed /documented in a GMP compliant manner and per applicable regulatory requirements
Facilitate communication and updates to Sampling Plan documents
Route sample plans change requests, track and escalate as necessary to area management
Develop strong relationship with lab personnel.At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves.
Join PPD in our relentless pursuit of excellence - apply now!
What To Expect Next
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.
Education and Experience:High / Secondary school diploma in a scientific field or equivalent and relevant formal academic / vocational qualification with preference to Bachelor's degree in a scientific field
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years) or equivalent combination of education, training, and experience.
Prior Sample Management and/or inventory management experience a plus
Prior experience in Quality Control and compliance a plus
Preferred Experience:
Bachelor's degree in a scientific field
Strong background with LIMS
Prior Sample Management and/or inventory management experience strongly preferred
Knowledge, Skills and Abilities:
Strong knowledge of the complete clinical supplies life cycle (i.e., manufacturing, packaging, labeling, import and export, storage and handling, distribution and delivery, return and reconciliation, final destruction)
Knowledge of cGMPs, safety regulations, and data integrity.
Strong attention to detail and ability to work under pressure
Sstrong computer skills: working knowledge of Microsoft Project, Excel, and Microsoft Word is required. LIMS strongly preferred
Experience working in a team environment, adaptability, self-motivation, and positive attitude
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures
Excellent interpersonal skills and problem solving/decision making skills.
Strong organizational skills required.
Focus on customer service aligned with highest standards of quality and excellence
Very strong communication skills both written and verbal
Fluent in English (verbal and written)
Working Environment:
PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
Able to work upright and stationary and/or standing for typical working hours
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments
Able to use and learn standard office equipment and technology with proficiency
May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
Keywords: "sample management" , "GMP" , "LIMS"
*LI-NW1
Education and Experience:High / Secondary school diploma in a scientific field or equivalent and relevant formal academic / vocational qualification with preference to Bachelor's degree in a scientific field
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years) or equivalent combination of education, training, and experience.
Prior Sample Management and/or inventory management experience a plus
Prior experience in Quality Control and compliance a plus
Preferred Experience:
Bachelor's degree in a scientific field
Strong background with LIMS
Prior Sample Management and/or inventory management experience strongly preferred
Knowledge, Skills and Abilities:
Strong knowledge of the complete clinical supplies life cycle (i.e., manufacturing, packaging, labeling, import and export, storage and handling, distribution and delivery, return and reconciliation, final destruction)
Knowledge of cGMPs, safety regulations, and data integrity.
Strong attention to detail and ability to work under pressure
Sstrong computer skills: working knowledge of Microsoft Project, Excel, and Microsoft Word is required. LIMS strongly preferred
Experience working in a team environment, adaptability, self-motivation, and positive attitude
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures
Excellent interpersonal skills and problem solving/decision making skills.
Strong organizational skills required.
Focus on customer service aligned with highest standards of quality and excellence
Very strong communication skills both written and verbal
Fluent in English (verbal and written)
Working Environment:
PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
Able to work upright and stationary and/or standing for typical working hours
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments
Able to use and learn standard office equipment and technology with proficiency
May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
Keywords: "sample management" , "GMP" , "LIMS"
*LI-NW1Submission for the position: Senior Sample Coordinator - Sample Management , LIMS , GMP - (Job Number: 171381)
Job posted: 2020-06-29