What are the responsibilities and job description for the Associate Specialist, Quality Systems position at BioSpace?
Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.
Job Description
The Associate Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
Responsibilities
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
US & Puerto Rico only - to learn more, visithttps://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
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.
Job Description
The Associate Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
Responsibilities
- Assist with proper integration and support of quality regulations: drug, biologics, device and/or combination products.
- Perform quality review of quality system and computerized system changes.
- Perform quality review of specifications associated with drug, biologics, device and/or combination products.
- Complete and route change requests for process document creation, maintenance, and implementation.
- Support project teams in planning, preparation, review and approval of quality documentation.
- Collect and compile key quality metric data.
- Participate in training and education programs for various aspects of quality assurance.
- Bachelors Degree (Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred) or equivalent experience.
- 0-2 years experience in quality assurance, quality oversight or relevant experience.
- Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological and medical device products preferred.
- Strong oral and written communication skills needed.
- Excellent interpersonal skills a plus.
- Delivers tactical results to support the quality system.
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 roleat thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on manyfactors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified 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 toparticipate in our short-term incentiveprograms.Note: No amount of payis considered to bewages or compensation until such amount isearned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthatare allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Companys sole andabsolute discretion, consistent withapplicable law.
US & Puerto Rico only - to learn more, visithttps://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