The Associate QC Scientist Microbiology is role 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.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.
**Multiple Positions for Multiple Shifts**- 1st Shift (M-F 8am - 5pm)- 2nd Shift (M-F 4pm - 12am)- 3rd Shift (M-F 12am - 8am)- 4th Shift (Weekends)**THE ROLE**- Primary responsibility is in Environmental Monitoring in classified cleanrooms.
Monitoring of surfaces, air, and non-viable air quality of ISO 5, 7, and 8 cleanrooms.- Conducts collection and testing of utilities such as USP water and clean steam- Conducts bioburden, endotoxin, TOC, and membrane filtration testing on cleaning, in-process and release samples.- Ability to isolate and sub-culture microorganisms for identification.- Performs a variety of microbiologic assays such as culture purity, growth promotion, culture viability, and other tests needed by the Quality Control group- Provides input on SOP revisions and may assist in the creation and editing of protocols- Builds credibility within the lab group by performing high quality work- Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns- Performs media fills and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity- Acts as Quality Control authority for aseptic flow and behavior within cleanrooms- Utilizes Excel to enter, compile, and trend environmental data for reporting purposes- May assist QC Manager/Supervisor with GMP and safety training of Quality Control staff- Works closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility- Effectively communicates results of own work through discussions and documentation with some input from supervisor- Flexibility in following unique campaign requirements that may include off-hour and weekend work- Other duties as assigned**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- Experience with Microsoft Excel and Microsoft Word- Strong attention to detail- Familiarity with Good Manufacturing Practices (cGMP s)- Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks**CATALENT 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 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 firstname.lastname@example.org for us to investigate with local authorities.
Location/Region: Harmans, MD (21077)