Quality Assurance Specialist
Bristol-Myers Squibb isa global biopharmaceutical company whose mission is to discover, develop anddeliver innovative medicines that help patients prevail over serious diseases.
One shared journeyis moving us forward at Bristol-Myers Squibb.
Around the world, we arepassionate about making an impact on the lives of patients with seriousdisease.
Empowered to apply our individual talents and ideas so that we canlearn and grow together.
And driven to make a difference, from innovativeresearch to hands-on community support.
Bristol-Myers Squibb recognizesthe importance of balance and flexibility in our work environment.
We offer awide variety of competitive benefits, services and programs that provideour employees the resources to pursue their goals, both at work and intheir personal lives.
This position is responsible for managing the timely releaseof incoming raw materials and consumables and for the assessment and closure ofdeviation investigations to ensure timely release of manufactured clinicalproducts.
This position is responsible for performing SAP transactions formaterial movements and disposition.
Responsibilities include and may not belimited to:
the review and approval of raw materialspecifications, raw material and test method qualification and transferdocuments, participation in vendor audits, preparation and review of qualityagreements, vendor risk assessments and new vendor approvals.
This position will also prepare quality metricsrelated to raw material release and deviation investigations for the routinequality council meetings.
This position will also manage deviationinvestigations related to raw materials, laboratory testing, GMP manufacturingoperations and facility controls.
This will involve conducting routinecross-functional investigation review meetings to support the lead investigatorsand to ensure the timely deviation closure.
The position will ensure that thoroughinvestigations are conducted in accordance with SOPs and appropriate correctiveand preventive actions are assigned to address the root cause with appropriateassessment of impact to product quality.
This position will be involved in authoring,review and approval of Standard Operating Procedures (SOPs) and other GMPdocuments.
This role will also provide qualityrepresentation at raw material planning meetings for new project launches andbe part ofthe risk assessment teams.
This position requires ability to workindependently with strong attention to detail, ability to drive performance andmeet metric commitments and ability to make informed decisions that impact materialor product release.
The position requires ability to be innovative,and help ensure high standards of quality and compliance are maintained at thesite.
Qualifications This position requires:
At minimum, a B.
S.
degree in a scientificdiscipline,A minimum of 7 years of related experience in thepharmaceutical or biologics industry with at least three years prior experiencein Quality Assurance.
Anextensive knowledge and understanding of FDA, EU and ICH guidelines and cGMPsrelated to the manufacturing of biopharmaceutical product.
Individual must have experience in managinginvestigations in a GMP manufacturing facility with familiarity in the use ofelectronic systems (i.
e.
TrackWise, SAP, LIMS and documentation managementsystems).
Topics are often of a complex technical nature orpertain to the interpretation of regulatory documents.
Requires ability to work independently anddemonstrate ability to exercise sound judgment in critical situations to assurecompliance with regulations and procedures while working under tight timelines.
Requires excellent communication skills and theability to work in a team based environment and interact well with otheremployees at various levels.
Personnel must demonstrate strong organizationalskills, flexibility and capability of handling several high priority itemssimultaneously on an ongoing basis.
Bristol-Myers Squibb is an equal opportunity employer - M/F/Vet/DisabilityRequisition ID - 1501313.
Estimated Salary: $20 to $28 per hour based on qualifications.
One shared journeyis moving us forward at Bristol-Myers Squibb.
Around the world, we arepassionate about making an impact on the lives of patients with seriousdisease.
Empowered to apply our individual talents and ideas so that we canlearn and grow together.
And driven to make a difference, from innovativeresearch to hands-on community support.
Bristol-Myers Squibb recognizesthe importance of balance and flexibility in our work environment.
We offer awide variety of competitive benefits, services and programs that provideour employees the resources to pursue their goals, both at work and intheir personal lives.
This position is responsible for managing the timely releaseof incoming raw materials and consumables and for the assessment and closure ofdeviation investigations to ensure timely release of manufactured clinicalproducts.
This position is responsible for performing SAP transactions formaterial movements and disposition.
Responsibilities include and may not belimited to:
the review and approval of raw materialspecifications, raw material and test method qualification and transferdocuments, participation in vendor audits, preparation and review of qualityagreements, vendor risk assessments and new vendor approvals.
This position will also prepare quality metricsrelated to raw material release and deviation investigations for the routinequality council meetings.
This position will also manage deviationinvestigations related to raw materials, laboratory testing, GMP manufacturingoperations and facility controls.
This will involve conducting routinecross-functional investigation review meetings to support the lead investigatorsand to ensure the timely deviation closure.
The position will ensure that thoroughinvestigations are conducted in accordance with SOPs and appropriate correctiveand preventive actions are assigned to address the root cause with appropriateassessment of impact to product quality.
This position will be involved in authoring,review and approval of Standard Operating Procedures (SOPs) and other GMPdocuments.
This role will also provide qualityrepresentation at raw material planning meetings for new project launches andbe part ofthe risk assessment teams.
This position requires ability to workindependently with strong attention to detail, ability to drive performance andmeet metric commitments and ability to make informed decisions that impact materialor product release.
The position requires ability to be innovative,and help ensure high standards of quality and compliance are maintained at thesite.
Qualifications This position requires:
At minimum, a B.
S.
degree in a scientificdiscipline,A minimum of 7 years of related experience in thepharmaceutical or biologics industry with at least three years prior experiencein Quality Assurance.
Anextensive knowledge and understanding of FDA, EU and ICH guidelines and cGMPsrelated to the manufacturing of biopharmaceutical product.
Individual must have experience in managinginvestigations in a GMP manufacturing facility with familiarity in the use ofelectronic systems (i.
e.
TrackWise, SAP, LIMS and documentation managementsystems).
Topics are often of a complex technical nature orpertain to the interpretation of regulatory documents.
Requires ability to work independently anddemonstrate ability to exercise sound judgment in critical situations to assurecompliance with regulations and procedures while working under tight timelines.
Requires excellent communication skills and theability to work in a team based environment and interact well with otheremployees at various levels.
Personnel must demonstrate strong organizationalskills, flexibility and capability of handling several high priority itemssimultaneously on an ongoing basis.
Bristol-Myers Squibb is an equal opportunity employer - M/F/Vet/DisabilityRequisition ID - 1501313.
Estimated Salary: $20 to $28 per hour based on qualifications.
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