at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States
Job Description
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.
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.
The Quality Coordinator assists with coordinating quality activities of a designated Customer Focused Team to ensure that goals and objectivesoftheteamareaccomplishedwithinprescribedtimeframesandinbudget.Helpsdriveprojectsuccessto provide PCI a competitive advantage in long-term quality customer management.
EssentialDutiesandResponsibilities:
1.Preparesanddistributesrequireddocumentationforrequestedproductionworkorders.
2.PerformdocumentationandrecordsreviewofcompletedorderstoensurecompliancewithcGMP'sand customer requirements.
3.Creatingandupdatingbatchrecords,formsandmaterialspecificationsaswellasorganizinginternaland customer approval of batch records and specifications.
4.Performsandsubmitsbatchrecords,accountabilityreportsand necessarydocumentationtocustomersto facilitate product release.
5.Helpidentify,communicate,trackandresolvedocumentrelatedissueswithotherdepartmentsand customers.
6.Functionasoneofthecustomerpointsforcommentsorquestionspertainingtobatchdocumentation.
7.Assistwithprovidingqualityrelatedmetrics.
8.Performsfinishedproductbatchreleaseofapprovedproductionlots.
9.Meetwithmanagementtoaddressissuesorconcernswiththebatchdocumentation.
10.Reviews and interprets customer standards, procedures and specifications for dissemination relative to batchrecords,formsandmaterialspecifications.Organizeinternalandcustomerapprovalofbatchrecords and specifications.
11.Thispositionmayrequireovertimeand/orweekendwork.
12.KnowledgeofandadherencetoallPCI,cGMP,andGCPpolicies,procedures,rules.
13.Attendancetoworkisanessentialfunctionofthisposition
PerformsotherdutiesasassignedbyManager/Supervisor.
Required Qualifications:
-TABEtestingrequirementsmetatapprovedgradelevelforposition.
-BasicMathematicalSkills
-IntermediateComputerSkills:Abilitytoperformmorecomplexcomputertasksandhasknowledgeof various computer programs.
-FullProfessionalProficiency:Abilitytospeak,read,andwritefluentlyandaccuratelyonalllevels pertinent to professional needs.
-VeryHighReasoning:Abilitytodefineproblems,collectdata,establishfacts,anddrawvalidconclusions.
Beabletointerpretanextensivevarietyoftechnicalinstructionsinmathordiagramformanddealwith several abstract/concrete variables.
Preferred Qualificaions:
-Abilitytofollowinstructionsandrespondtomanagementdirection.
-Abilitytoidentifyandresolveproblemsinatimelymanner.
-Abilitytoholdoneselfinaprofessionalmanner.
-Abilitytodemonstrateattentiontodetail.
-HighSchoolDiplomaorGED
- 2yearsofexperienceinOperations/Qualityand/orprovidingsupportinanofficeormanufacturing environment. .
#LI-LL1
Join us and be part of building the bridge between life changing therapies and patients.
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.
