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Production Inspector - 2nd Shift

Catalent Pharma Solutions

Catalent Pharma Solutions

Production Inspector - 2nd Shift

Kansas City, KS
Full Time
Paid
  • Responsibilities

    POSITION SUMMARY:

    The Production Inspector, Quality is responsible for quality oversight of all packaging and distribution "floor" activities and the associated in-process GMP records. The scope of this role includes quality support of supply chain, production, storage, returned goods and destruction activities and may require simultaneous auditing and/or monitoring of one or more operators. In addition to day-to-day responsibilities, the Production Inspector, Quality will identify and participate in opportunities to improve processes.

    Monday-Friday: 2:30PM-11:00PM

    $1,500 Sign On Bonus

    CATALENT IS COMMITTED TO A PATIENT FIRST CULTURE THROUGH EXCELLENCE IN QUALITY AND COMPLIANCE, AND TO THE SAFETY OF EVERY PATIENT, CONSUMER AND CATALENT EMPLOYEE.

    THE ROLE:

    • Responsible for ensuring that Standard Operating Procedures are consistently followed and that cGMP's are observed, in the course of packaging operations. This may require simultaneous auditing and/or monitoring of one or more operations. Performs walk through audits of the production floor, clean storage rooms, warehouse and associated areas to ensure cGMP are being followed.

    • Verifies and reconciles materials to and from Clinical Production rooms and works accordingly with Production, Materials Management and Project Management to handle any possible discrepancies.

    • Inspects and releases all clinical packaging rooms to ensure that they have been properly cleaned and that all materials have been removed. Documents all activities accordingly in the associated logbook. Reviews production logbooks for GMP compliance as each operation is completed and revises SOPs as needed.

    • Supports and assists Mechanics on the execution of Operational Verifications (OVs) and Set-Up Records (SURs) both prior to the start and during the process (if necessary) for any jobs using validated or non-validated equipment respectively.

    • Reviews and understands both the production protocol and QA protocol prior to starting the Clinical Packaging process

    • Performs and documents hourly QA Inspections on assigned clinical packaging rooms as per both the QA protocol and SOPs requirements as well as ensuring that the production protocol and GMP standards are being followed. Reviews the batch record and any associated paperwork for any documentation errors made during the clinical packaging operation and again when the job is completed prior to submitting the batch record to document control.

    • Reviews EMS system printouts for out of specification temperatures, humidity and pressures.

    • Prints and review Material Usage Reports for each clinical packaging job and/or operation to ensure that the drug product quantities documented in the batch record match those that are entered in the Inventory Management System. Ensures all Inventory Management System printed labels are correct against the information provided in the associated protocol.

    • Other duties as assigned.

    THE CANDIDATE:

    • High school diploma required, Associates degree highly preferred in a life sciences or business related field.

    • Minimum of 1 year production/QA experience; 3 years highly desired. Track record of monitoring/auditing for a quality organization and identifying potential efficiencies in a Production environment.

    • Utilize all elements of the quality system to identify, classify and control the status of finished products produced

    • On an average 8 hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds.

    • May require the use of a respirator.

    • Has sufficient skills and knowledge in the use of computers and associated computer technology. Computer technology relates to both the hardware and software used in performing common computing tasks. (Word, Excel, Outlook, PowerPoint basics)

    WHY YOU SHOULD JOIN CATALENT:

    • Medical, Dental, Vision and 401K are all offered from day one of employment

    • 19 days of paid time off annually

    • Potential for career growth within an expanding team

    • Defined career path and annual performance review and feedback process

    CATALENT OFFERS REWARDING OPPORTUNITIES TO FURTHER YOUR CAREER!

    Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

    Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

    personal initiative. dynamic pace. meaningful work.

    Visit Catalent Careers to explore career opportunities.

    Catalent is an Equal Opportunity Employer, including disability and veterans.

    If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

    Notice to Agency and Search Firm Representatives:

    Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

    Important Security Notice to U.S. Job Seekers:

    Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

  • Industry
    Pharmaceuticals
  • About Us

    Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development directly to patient. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.