Quality Assurance Admin
Job DescriptionResponsibilities include review of documentation related to Customer Release and Ship under Quarantine Memos.
Maintain and organize the SPS Allentown E-mail.
Will follow up on customer inquiry e-mails.
Process customer release documentation for product distribution.
Responsibilities also include working with the Warehouse to communicate any quantity discrepancies with QAD against the executed batch records.
Keep PQ/PV Records up to date on closures with QA Validation department.
Performs Labor Feedback data entries in QAD as well as keeping the Quality Dashboard up to date when processing Ship under Quarantine Memos and Customer Release Documentation.
The impact of administrative responsibilities directly impacts company compliance to regulatory requirements and customer satisfaction.
ESSENTIAL DUTIES AND
Responsibilities:
The following is a list of responsibilities related to administration.
Other duties may also be assigned.
oResponsible for the understanding and handling of documentation related to Ship in Quarantine memos and Customer Release documentation.
oResponsible for follow-up on all customer inquiries specific to documentation related to the packaging, testing and release of the work in-process or finished product.
oResponsible for processing final customer release of work in-process or finished goods.
oResponsible for reviewing and maintaining the QAD Item Master Maintenance and Router MaintenanceoResponsible for filing and archiving of completed executed packaging records.
oResponsible for maintaining and filing of documentation related to packaging in current appropriate status locations.
oResponsible for tracking lot statuses.
oResponsible for participating in internal, customer, and regulatory audits at the discretion of management.
oOther responsibilities as required.
Send Batch Records - might have to go from one building to the other as Sharp has multiple buildings.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duties and responsibilities satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functionsRequirementsoHigh School Degree is required.
oOne to two years related pharmaceutical experience and/or training; or equivalent combination of education and experience is preferred.
oExperience in pharmaceutical or related industry is desired.
oGeneral knowledge of FDA regulations related to cGMPs required.
oGeneral knowledge of cGDPs required.
oGeneral knowledge of quality control/assurance required.
oGeneral knowledge of DEA regulations preferred.
oExcellent detail skills as they apply to documentation review and compliance required.
oGood written and oral communication skills required.
-oGood organizational and planning skills required.
oExcellent interpersonal skills required Recommended Skills Administration Auditing Communication Filing Food Safety Interpersonal Skills Estimated Salary: $20 to $28 per hour based on qualifications.
Maintain and organize the SPS Allentown E-mail.
Will follow up on customer inquiry e-mails.
Process customer release documentation for product distribution.
Responsibilities also include working with the Warehouse to communicate any quantity discrepancies with QAD against the executed batch records.
Keep PQ/PV Records up to date on closures with QA Validation department.
Performs Labor Feedback data entries in QAD as well as keeping the Quality Dashboard up to date when processing Ship under Quarantine Memos and Customer Release Documentation.
The impact of administrative responsibilities directly impacts company compliance to regulatory requirements and customer satisfaction.
ESSENTIAL DUTIES AND
Responsibilities:
The following is a list of responsibilities related to administration.
Other duties may also be assigned.
oResponsible for the understanding and handling of documentation related to Ship in Quarantine memos and Customer Release documentation.
oResponsible for follow-up on all customer inquiries specific to documentation related to the packaging, testing and release of the work in-process or finished product.
oResponsible for processing final customer release of work in-process or finished goods.
oResponsible for reviewing and maintaining the QAD Item Master Maintenance and Router MaintenanceoResponsible for filing and archiving of completed executed packaging records.
oResponsible for maintaining and filing of documentation related to packaging in current appropriate status locations.
oResponsible for tracking lot statuses.
oResponsible for participating in internal, customer, and regulatory audits at the discretion of management.
oOther responsibilities as required.
Send Batch Records - might have to go from one building to the other as Sharp has multiple buildings.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duties and responsibilities satisfactorily.
The requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functionsRequirementsoHigh School Degree is required.
oOne to two years related pharmaceutical experience and/or training; or equivalent combination of education and experience is preferred.
oExperience in pharmaceutical or related industry is desired.
oGeneral knowledge of FDA regulations related to cGMPs required.
oGeneral knowledge of cGDPs required.
oGeneral knowledge of quality control/assurance required.
oGeneral knowledge of DEA regulations preferred.
oExcellent detail skills as they apply to documentation review and compliance required.
oGood written and oral communication skills required.
-oGood organizational and planning skills required.
oExcellent interpersonal skills required Recommended Skills Administration Auditing Communication Filing Food Safety Interpersonal Skills Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
