BioSpace, Inc.
Job Details
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Purpose:
The primary responsibility for the Quality Validation Specialis t is theQuality oversight and overall approval of validation and engineering change management activities. The Validation engineering department, will support the implementation of the Validation quality program,and will be expected to independently manage 5+ key projects simultaneously.
Responsibilities:
Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements
Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility
Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended
Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy
Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation
May supervise contract validation resources in the timely completion of activities in his/her area of responsibility
May lead, author, or review investigations and implementation of preventive and corrective action
.
Qualifications
Qualifications:
Bachelor's Degree Required (preferably in Biology, Chemistry or Engineering)
6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
Strong verbal and written communication skills
Solid problem solving and analytical skills
Solid interpersonal skills, including ability to negotiate/influence without authority
Ability to manage complex projects and multiple projects (5+) simultaneously
Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
Key Stakeholders
Various stakeholders within the site including but not limited to Plant Operations, Quality, Engineering/Maintenance, and Science & Technology
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's soleandabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , and YouTube .
Stock Symbol:
ABBV
Stock Exchange:
NYSE
Company info Website http://www.abbvie.com/ Phone 1-800-255-5162 Location 1 North Waukegan Road North Chicago Illinois 60064 United States
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Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Purpose:
The primary responsibility for the Quality Validation Specialis t is theQuality oversight and overall approval of validation and engineering change management activities. The Validation engineering department, will support the implementation of the Validation quality program,and will be expected to independently manage 5+ key projects simultaneously.
Responsibilities:
Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements
Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility
Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended
Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy
Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation
May supervise contract validation resources in the timely completion of activities in his/her area of responsibility
May lead, author, or review investigations and implementation of preventive and corrective action
.
Qualifications
Qualifications:
Bachelor's Degree Required (preferably in Biology, Chemistry or Engineering)
6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
Strong verbal and written communication skills
Solid problem solving and analytical skills
Solid interpersonal skills, including ability to negotiate/influence without authority
Ability to manage complex projects and multiple projects (5+) simultaneously
Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
Key Stakeholders
Various stakeholders within the site including but not limited to Plant Operations, Quality, Engineering/Maintenance, and Science & Technology
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's soleandabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , and YouTube .
Stock Symbol:
ABBV
Stock Exchange:
NYSE
Company info Website http://www.abbvie.com/ Phone 1-800-255-5162 Location 1 North Waukegan Road North Chicago Illinois 60064 United States
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