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1+ months

Associate Quality Analyst

Kelly Services
Barceloneta, PR 00617
Associate Quality Analyst

During routine operations, the Associate SVP Quality Analyst is responsible for carrying out Manufacturing Quality Assurance functions within the ABL plant including the coordination of Line Inspections, Quality Visual Inspections and Tub Hold management process. The incumbent supports the visual inspection certification process, is responsible for the approval of manufacturing directions to the production floor, resolution of deviations, performance of product impact analysis and corrective and preventive action for events, participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of compliance with cGMP and Abbvie policies for the manufacturing plant.


The Associate SVP Quality Analyst may support the ABL Quality Engineering group by auditing commissioning and validation documentation, authoring and execution of qualification/validation protocols, review and approval of critical planned maintenance routines, set-up of laboratory samples for qualification, and other quality assurance tasks assigned by the SVP QA Superintendent or SVP QA Operations Manager and/or the Plant QA Manager.


Responsible for coordinating the SVP Line Inspections, Quality Visual Inspection (i.e. AQL) and Tub Hold Management process.

Supports Visual Inspection Certification Process. May act as Subject Matter Expert (SME) for the Visual Inspection Process.

Support quality goals ensuring that all practices and procedures comply with GPO and Corporate policies and applicable regulations for the Quality areas under his/her responsibility.

Support SVP Media Fill Program and QA Oversight execution activities.

Performs product impact analyses for plant events and places product on QA hold when required. Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.

Revise and/or approves standard operating procedures; ensures procedures comply with AbbVie policies and cGMP guidelines.

Approves calibration requests and ensure that these requests have appropriate product/process limits assigned

o Support SVP drug product batch record documentation review.


The preference is to have candidates with experience in Quality Assurance and/or parenteral products manufacturing process. Prior experience in parenteral drug products Visual Inspection process is preferred. Candidates will be hired for work during the 2nd or 3rd shift.


Qualifications:


Educational Requirements:

Bachelors Degree in Science (preferably on Biology, Chemistry or Biotechnology) or Engineering.

Knowledge and experience in manufacturing of biotechnology products and GMPs is needed.


Experience working in a Biotechnology Manufacturing Plant in areas of manufacturing or quality 2 Years

Experience working in highly computerized Operations environments 1 Year

Total combined minimum years of experience 2 years.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-04-11 Expires: 2022-06-11

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Associate Quality Analyst

Kelly Services
Barceloneta, PR 00617

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