Quality Assurance Manager

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Job description

Kelly ® Science & Clinical is seeking Quality Assurance Manager professionals who are eager to bring the latest scientific discoveries to life in order to create a brighter, safer and healthier future for all. If you're passionate about shaping the world we live in and ready for a new challenge, this may be the perfect opportunity for you.

Responsible for managing all Quality Assurance aspects of compounding sterile pharmaceuticals for compliance within the facility. Operates within the legal and regulatory compliance, producing a quality product. Operates the area as the manager over the QA operations/staff, coordinating day to day functions.

How will you make an impact?

• Manages all Manufacturing QA staff providing learning and development where appropriate.
• Ability to make QA decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations.
• Responsible for timely and accurate in process review of batch records and QA checks within the manufacturing process.
• Provides review/approval of Deviations / Investigations, CAPAs, Change Controls.
• Generates procedures related to Manufacturing QA functions / activities.
• Designs and maintains the environmental monitoring program including environmental and personnel monitoring results that exceed alert or action limits and interpreting results.
• Trains personnel on appropriate aseptic techniques and gowning techniques.
• Periodically review records to verify that quality standards for each drug product is met.
• Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws is a nice to have
• submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities.
• Responsible for maintaining QA records associated with internal and external testing.
• Responsible to maintain all testing equipment in compliance, calibration and certification.
• Assists in developing policies and procedures related to QA.
• Promptly communicates with Operations regarding complaints, product issues/variances.
• Enforces applicable personnel policies and procedures.

Minimum Qualifications:

• Bachelor's degree in Engineering or Science or related scientific discipline, or equivalent. Higher degree/PhD will be preferred for senior level positions.
• Relevant regulated industry experience (i.e., FDA or EMA).
• Experience working at the FDA is highly preferred.
• Experience filing IND/NDA submissions (check which Phase of Clinical Development the talent has, or the client requires).
• Experience with interacting with specific Divisions within the FDA (i.e., CDER or CBER).
• Knowledgeable of FDA Clinical Trial Guidance's and regulations, pharmaceutical development process, and industry standard practices.
• Prepare scientific and regulatory documents such as study protocols, investigator brochures, informed consent forms, annual reports, IND applications, IDE applications, and summary report.
• Regulatory correspondence with PI's and on-site monitors to communicate and educate involved parties on new protocols, amendments, and continual review updates.
• Maintain TMF related to ongoing studies and all regulatory documentation.
• Working knowledge of database management programs, analytical tools, and CTMS.

#TJP2021_SPEC

#TJP2021_SCT

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.

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 interests-it's 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.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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.

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