Quality Supervisor

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 Supervisor is responsible for leading efforts in planning, directing, and coordinating customer focus team Quality activities in ordertoensurethatthequalityofPCI'sproductsareincompliancewithcustomerrequirementsaswellasstateand federal regulations. Lead and play an integral part in individual project success and provide PCI a competitive advantage in long-term customer management.

Essential Duties and Responsibilities:

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.

Qualifications:
Required:
-Bachelor'sDegreeinarelatedfieldand/or1-5yearsrelatedexperienceand/ortraining.
-CollegeLevelMathematicalSkills
-AdvancedComputerSkills:Abilitytoperformthemostcomplexcomputertasksandoperatevarious computer programs.
-FullProfessionalProficiency:Abilitytospeak,read,andwritefluentlyandaccuratelyonalllevels pertinent to professional needs.
-High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situationswherethereisonlylimitedstandardization.Abilitytointerpretavarietyofinstructionsthatmay be provided in various forms.

Preferred:
- Abilitytoeffectivelypresentinformationtovariouspeopleasthejobrequires.
-Abilitytoidentifyandresolveproblemsinatimelymanner.
- Abilitytotravel.

Join us and be part of building the bridge between life changing therapies and patients.

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.

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Join us and be part of building the bridge between life changing therapies and patients.

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.

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.