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25 days old

Quality Assurance Manager - Manufacturing

Kelly Services
Chicago, IL 60684
**Kelly Services is actively recruiting for a Direct Hire opportunity in Chicago, Illinois for a Manufacturing Quality Assurance Manager!**


**Responsibilities of the Manufacturing Quality Assurance Manager includes:**


+ Contributes to the development and implementation of Quality Assurance procedures governing the facility Manufacturing operations and ensures compliance with cGMP regulations, customer expectations and company policies.

+ Ensures immediate addressing of nonconformance through triage and oversight of investigations and deviations.

+ Conducts or oversees AQLs of vial / syringe visual inspection.

+ Performs or oversees performance of line inspection / clearance.

+ Collaborates on the development of Manufacturing, warehouse and Quality SOPs.

+ Responsible for review of batch records, engineering and calibration records, and other documents associated with the manufacturing process.

+ Reviews and approves Certificates of Analysis.

+ Acts as SME for manufacturing records for regulatory or client audits.

+ Leads manufacturing Quality Investigations. Collaborates with cross functional teams to resolve Quality issues, identify root cause and implement necessary CAPAs.

+ Coordinate the administration of the Corrective Action and Preventive Action Program and ensure activities are completed in a timely manner and ensure that status reports and extensions are completed as required.

+ Monitors effectiveness of Quality Systems, developing event metrics such as number and type of batch record errors, training deviations, etc., and trend analysis for management review, escalates issues and drives resolution.

+ Provide training to MQA associates and other members, as required.

+ Supervises and directs the activities of MQA associates, including planning, scheduling and performance reviews.

+ Has familiarity with USP, cGMP, ISO, Code of Federal Regulations (CFR) guidelines and ICH guidelines

+ Provide backup of Site Quality Heads responsibilities.

+ Other duties as requested by management


**Qualifications required for the Manufacturing Quality Assurance Manager includes:**


+ BS degree in life sciences (Biology, Chemistry, etc.) with 5-7 years relevant industry (Biotech/Pharma) experience.

+ MS degree in life sciences with 3-5 years relevant industry (Biotech/Pharma) experience.

+ Knowledge of GMPs and their application in the commercial environment is required.

+ Working experience in an aseptic processing facility.

+ Ability to work independently or in teams both within department and cross-functionally. Must be able to organize, plan and manage assigned tasks to bring projects to completion.

+ Strong and clear communication skills, both written and verbal.

+ Presentation of data and reports to small/large groups is part of the job.

+ Excellent organizational skills and detail oriented. Must have excellent time management skills and the ability to effectively prioritize assignments.

+ Thorough knowledge of GMPs

+ Requires the ability to influence and change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.

+ Exercises due professional care and works with a high level of integrity.


**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: 2021-11-05 Expires: 2021-12-30

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Quality Assurance Manager - Manufacturing

Kelly Services
Chicago, IL 60684

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