Associate Scientist - QC

Company: Disability Solutions
Location: Bloomington
Posted on: October 24, 2024

Job Description:

Associate Scientist - QCPosition 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 Associate Scientist - QC will perform routine testing of process samples, raw materials, finished products and stability samples, while adhering to SOPs and working in a cGMP compliant environment.This position is Friday-Monday 6PM-6AM Weekend PM shift and 100% on site at our 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:------- --Carries out Microbiology testing such as, microbial enumeration testing and endotoxin testing, data analysis, document writing, and data reporting to support the manufacturing and release of bulk drug substance and drug product.------- --Evaluates the effectiveness of microbial controls necessary to ensure that the manufacturing facility is maintained in a manner that prevents the ingress of microorganisms in low bioburden products by performing routine and investigational sampling of the manufacturing environment and associated facilities.------- --Independently executes and properly documents cGMP Quality Control testing; independently operates basic and moderately complex cGMP Quality Control equipment.------- --Assists in authoring technical documents such as SOPs and reports; coordinates with Supervisor to prioritize and schedule activities to meet deadlines.------- --Supports continuous process improvement initiatives; enters data into Laboratory Information Management System (LIMS) or laboratory reports; accurately completes routine and preventive maintenance on basic to moderately complex equipment.------- --Other duties as assignedThe Candidate:------- --Bachelor in a science field required with experience working in a cGMP QC laboratory preferred.--------- --General laboratory equipment experience, including micropipettes required------- --Preferred: Basic understanding of analytical chemistry and simple lab equipment; familiarity with clean room procedure, aseptic technique, and general lab equipment experience; cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) knowledge.------- --Ability to maintain batch records and/or laboratory notebook and complete all laboratory documentation in clear and accurate language and according to SOP; ability to attend training and apply learning on routine operation, maintenance, and theory or laboratory instrumentation, SOPs, and regulatory guidelines; ability to use Excel, Word, and other Office systems.------- --Ability to add, subtract, multiply, divide and to record, balance, and check results for accuracy; ability to peer review data to ensure data is well organized with complete documentation; ability to understand and independently apply GMPs to everyday work with regard to documentation and instrument use; ability to apply applicable regulatory authority and guidelines with training.------- --Ability to maintain lab equipment; ability to operate within a clean room environment as needed; Accountable for owning, reviewing and approving documentation such as procedures, method and protocols; accountable of owning laboratory investigations, within the quality systems------- --Must be able to read and understand English-written job instructions and safety requirements.------- --Environmental requirements: Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening; occasional stooping, kneeling, crouching, bending, carrying, grasping; frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds; Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.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 .

Keywords: Disability Solutions, Noblesville , Associate Scientist - QC, Other , Bloomington, Indiana