Principal Representative, QA

Company: Disability Solutions
Location: Bloomington
Posted on: October 23, 2024

Job Description:

Principle Quality Assurance Representative--Position Summary--Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--Catalent Biologics in Bloomington, Indiana is a state-of-the art, GMP manufacturing facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.-----The Principle Quality Assurance Representative will work with a team to develop and implementing sterility assurance and microbiology strategies, policies, and procedures for the company's manufacturing facility.--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.This position is 1st shift Monday-Friday 6AM-2PM with off-shift and weekend work as needed. Position is 100% on site at Catalent's Bloomington, Indiana facility.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:------- --The scope to work with a cross functional team to develop and establish the sterility assurance program for a state-of-the-art Pharmaceutical manufacturing facility ensuring excellent compliance--------- --Assist leadership in the implantation of quality systems procedures and handling compliance across the department--------- --Participate in regulatory inspections and assist in leading the quality assessment of internal operations for any risks--------- --Responsible along with the team for the Contamination Control Strategy and Sterility Assurance to ensure and improve clean room controls within the facility to minimize risk and cross-contamination--------- --Other duties as assignedThe Candidate:--------- --BS degree in Science, preferably in Biology or Microbiology; Master's degree preferred.--------- --8+ years experience with Microbiology, sterility assurance and aseptic processing within pharmaceutical/biotech manufacturing--------- --Minimum of 4 years GxP experience, or other regulated industry.------- --Strong regulatory knowledge of industry standards related to sterile manufacturing and aseptic processing--------- --Experience with regulatory inspections and audits--Why you should join Catalent:------- --Defined career path and annual performance review and feedback process--------- --Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives--------- --Dynamic, fast-paced work environment------- --Generous 401K match and Paid Time Off accrual--------- --Medical, dental and vision benefits effective day one of employment--------- --Tuition Reimbursement--------- --Wellhub program to promote overall physical wellness--------- --Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories--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.--personal initiative. dynamic pace. meaningful work.Visit 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 . 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.California Job Seekers can find our California Job Applicant Notice .

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