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17 days old

Manufacturing Quality Assurance

Kelly Services
North Chicago, IL 60064
Kelly is currently looking for Manufacturing Quality Assurance candidates with a top fortune 500 company.


**Title:** Manufacturing Quality Assurance


**Duration:** 6 Months (Possibility of Extension 1 year or Conversion for the potential Candidates.


**Location:** North Chicago Illinois


**Engineer, Quality/Supplier Quality Engineer Job description:**


**Purpose:**


Describe the primary goals, objectives or functions or outputs of this position.


The Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant.


**Responsibilities:**


Assist Validation Engineer in the validation and certification of all new process equipment and periodically review all certified systems to assure the capability of meeting quality requirements.


Responsible for implementing and maintaining the effectiveness of the Quality System.


Support to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations.


Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.


Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.


Participates on the Validation Review Board as the Manufacturing Quality Assurance function.


Approves standard operating procedures; ensures procedures comply with policy and make sense.


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


Develop and implement statistical quality programs, assure all acceptance sampling is capable of meeting expected product quality confidence levels for manufactured as well as purchased materials.


**Qualifications:**


Bachelor's degree, preferably in Biology, Chemistry or Engineering or equivalent related experience


2+ years of overall experience in Manufacturing, Quality or Engineering


Good verbal and written communication skills.


Good problem solving and analytical skills


Good interpersonal relations / communications skills


Good negotiation skills


Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.


**Years of experience/education and/or certifications required:**


+ Bachelor's degree, preferably in Biology, Chemistry or Engineering or equivalent related experience

+ 2+ years of overall experience in Manufacturing, Quality or Engineering


**What are the top 3-5 skills requirements should this person have?**


+ Good problem solving and analytical skills

+ Good interpersonal relations / communications skills

+ Good negotiation skills (will deal with suppliers on specification agreements)

+ Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

+ Knowledge of packaging materials and commodities and how quality regulations impact them.


**What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?**


Experience with incoming quality and supplier quality agreements.


**Additional notes from Manager:**


+ Fairly fast paced dealing with multiple different suppliers during any given day or week.

+ Successful candidate background: Incoming quality technicians, supplier quality analyst.


**Work Schedule (Define days,# of hours)/ Is Overtime offered or required?**


Standard 40 hour work week- 8am-430pm (flexible)


**Does this position offer the ability to work remotely on a regular basis?**


Remote is available part time after onboarding is completed.


**Interview Process**


1 hour onsite interview


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


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2022-05-09 Expires: 2022-06-09

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Manufacturing Quality Assurance

Kelly Services
North Chicago, IL 60064

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