Clinical Operations Specialist - II (Associate)
Job ID:
23-06521
Qualifications:
Title:
Operations Planner-II Education:
High School/Associate degree/Bachelor's degree/Master's degree.
Work Experience Requirements:
o3-5 years' experience in the pharmaceutical industry and/or clinical supply knowledge.
oKnowledge of GMP guidelines.
oPharmaceutical industry experience.
oLabel design experience.
Preferred Experience and Skills:
oStrong verbal and written communication skills.
oDetail oriented.
oDirect work experience with SAP is a plus.
oFlexible and team oriented.
oDiligent and quality oriented.
oStructured and proactive working attitude.
Note:
Hybrid role:
4 days onsite/1 day remote.
Work location:
West Point,PA.
Do not submit PHD candidates.
Positions available:
2 Responsibilities:
Responsible for independently coordinating all activities associated with timely packaging, labeling, and assembly of clinical materials for designated domestic and international studies in accordance with applicable safety and regulatory requirements as well as company policies.
This individual is responsible for execution of clinical supplies activities including but are not limited to the processing of study specific packaging and labeling documentation, coordinate packaging job progress, and review of documentation and procedures.
Label Room
Responsibilities:
Core Responsibilities:
oRead comprehend and translate clinical trial protocols /packaging specifications into clinical label generation software.
oDesign clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the Client label systems.
Interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.
oCoordination of Translation Requests oGeneration of Clinical Label Proofs with CLPG oLiaise with country-level Clinical Operations personnel or Regulatory Affairs to address questions, revise translations, update regulatory requirements, etc.
oMaintain Label Translations library.
oInterpret clinical study design and Clinical Supply Strategy (CSS) oDesign and verify label models.
oCoordinate MLBL manufacturing at vendors oPerform visual inspection and accountability for label proofs.
oProvide detailed analysis of issues and collaborate for creative problem solving.
oLiaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or other stakeholders.
oTrain Label Project Coordinator Level I team members and remain proficient in appropriate systems and software.
oResponsible for ensuring scheduling and timelines are maintained.
oCoordinate with key stakeholders to maintain schedule adherence and maintain key metrics.
oMay utilize SAP, CSLS, CLPG, eShopFloor, CSST Appian, Microsoft Office, Excel Additional Responsibilities:
(including but not limited to) oAdhere to dress code policy.
oComplete all the trainings as required.
oComplete GMP documentation oContributing to or author SOPs, CJAs, BTDs, and Job Aids oContribute to or author investigations.
oContribute to or define and manage CAPAs.
oReport potential quality events, non-conformance to GMPs/SOPs when observed.
oGenerate Change Control/Change Management records.
oManage Re-Packaging and R.
E.
D.
Extension packaging jobs, including drug salvage operations.
oAnalyzes and anticipates technical problems and obstacles as they relate to clinical supplies packaging and participates in adjustment of logistics pertaining to drug supply.
Recommended Skills Assembly And Installation Attention To Detail Change Management Clinical Study Design Clinical Trial Protocols Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
23-06521
Qualifications:
Title:
Operations Planner-II Education:
High School/Associate degree/Bachelor's degree/Master's degree.
Work Experience Requirements:
o3-5 years' experience in the pharmaceutical industry and/or clinical supply knowledge.
oKnowledge of GMP guidelines.
oPharmaceutical industry experience.
oLabel design experience.
Preferred Experience and Skills:
oStrong verbal and written communication skills.
oDetail oriented.
oDirect work experience with SAP is a plus.
oFlexible and team oriented.
oDiligent and quality oriented.
oStructured and proactive working attitude.
Note:
Hybrid role:
4 days onsite/1 day remote.
Work location:
West Point,PA.
Do not submit PHD candidates.
Positions available:
2 Responsibilities:
Responsible for independently coordinating all activities associated with timely packaging, labeling, and assembly of clinical materials for designated domestic and international studies in accordance with applicable safety and regulatory requirements as well as company policies.
This individual is responsible for execution of clinical supplies activities including but are not limited to the processing of study specific packaging and labeling documentation, coordinate packaging job progress, and review of documentation and procedures.
Label Room
Responsibilities:
Core Responsibilities:
oRead comprehend and translate clinical trial protocols /packaging specifications into clinical label generation software.
oDesign clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the Client label systems.
Interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.
oCoordination of Translation Requests oGeneration of Clinical Label Proofs with CLPG oLiaise with country-level Clinical Operations personnel or Regulatory Affairs to address questions, revise translations, update regulatory requirements, etc.
oMaintain Label Translations library.
oInterpret clinical study design and Clinical Supply Strategy (CSS) oDesign and verify label models.
oCoordinate MLBL manufacturing at vendors oPerform visual inspection and accountability for label proofs.
oProvide detailed analysis of issues and collaborate for creative problem solving.
oLiaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or other stakeholders.
oTrain Label Project Coordinator Level I team members and remain proficient in appropriate systems and software.
oResponsible for ensuring scheduling and timelines are maintained.
oCoordinate with key stakeholders to maintain schedule adherence and maintain key metrics.
oMay utilize SAP, CSLS, CLPG, eShopFloor, CSST Appian, Microsoft Office, Excel Additional Responsibilities:
(including but not limited to) oAdhere to dress code policy.
oComplete all the trainings as required.
oComplete GMP documentation oContributing to or author SOPs, CJAs, BTDs, and Job Aids oContribute to or author investigations.
oContribute to or define and manage CAPAs.
oReport potential quality events, non-conformance to GMPs/SOPs when observed.
oGenerate Change Control/Change Management records.
oManage Re-Packaging and R.
E.
D.
Extension packaging jobs, including drug salvage operations.
oAnalyzes and anticipates technical problems and obstacles as they relate to clinical supplies packaging and participates in adjustment of logistics pertaining to drug supply.
Recommended Skills Assembly And Installation Attention To Detail Change Management Clinical Study Design Clinical Trial Protocols Clinical Works Estimated Salary: $20 to $28 per hour based on qualifications.
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