Associate Specialist, Quality Systems
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Barceloneta, Barceloneta
- Operations
- Manufacturing Process
- Full-time
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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.
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.
- Conduct initial regulatory review of documents.
- Assist with audits of documentation, facilities and equipment.
- 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.
- Perform QA review for product release.
- Participate in training and education programs for various aspects of quality assurance.
Significant Work Activities
- Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
- Frequent to continuous computer usage (greater or equal to 50% of the workday) is required.
Qualifications
- Bachelor’s 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 or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
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