Associate QC Scientist - Microbiology

3 days left

Employer
Catalent Pharma Solutions
Location
Harmans, Maryland, US
Salary
Competitive
Posted
Jun 26, 2021
Closes
Aug 07, 2021
Ref
2311560986
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
Job Description
Position Overview:
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
This Associate QC Scientist is responsible for Environmental Monitoring sampling, analyzing, and aseptic monitoring and microbiological testing to support Phase I/II GMP manufacturing. Works in a fast-paced environmental supporting the quality control department of a CMO for manufacturing of biologic bulk drug substance, sterile finished drug product, and fill/finish.
Position workweek is Monday-Friday (8am-5pm) and will reside at the Harmans/BWI campus.
Catalent Cell & Gene Therapy hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.
The Role:
- Perform Environmental Monitoring Cleanrooms, including sampling of viable surfaces, viable air and non-viable particulates in a Phase III/Commercial GMP Manufacturing facility.
- Conducts routine sampling and testing of Clean Utilities such as USP water (WFI) and clean steam along with conducting bioburden testing on prepared buffers/solutions, equipment cleaning samples, in-process and release drug product samples.
- Ability to isolate and sub-culture microorganisms for identification.
- Provides input on SOP revisions and may assist in the creation and editing of protocols.
- Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns. Effectively communicates results of own work through discussions and documentation with some input from supervisor.
- Performs Aseptic Process Simulations (media fills) and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity.
- Compilation and trending of Environmental Monitoring data for reporting purposes.
The Candidate:
- B.S. or A.S. in a Life Sciences discipline and 0-4 years of relevant experience working in cGMP cleanrooms.
- Experience working in cGMP Quality Control - Good Manufacturing Practices (cGMP's).
- Flexibility in following unique campaign requirements that may include off-hour and weekend work.
- Experience with Microsoft Excel and Microsoft Word. Strong exposure and attention to detail to revising SOP's and analyzing data.
- Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
- Ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision.
- Experience with viable and non-viable Environment Monitoring collection instruments.
We will identify candidates based on the following:
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
Position Benefits
- Potential for career growth within an expanding team
- Defined career path and annual performance review & feedback process
- Cross functional exposure to other areas of within the organization
- Medical, Dental, Vision, and 401K are all offered from day one of employment
- 19 days of paid time off annually + 8 paid holidays
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 www.catalent.com/careers to explore career opportunities.
C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.
Catalent = Catalyst + Talent
Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!
personal initiative. dynamic pace. meaningful work.
Catalent is the perfect place to grow your career if...
- You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
- You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year - more than any branded drug maker in the world!
- You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
- You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
- You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking (https://catalent.wd1.myworkdayjobs.com/External) for YOU!
- See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .

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