SevernRecruiter Since 2001
the smart solution for Severn jobs

Quality Control Lead Analyst (2nd Shift)

Company: Catalent
Location: Severn
Posted on: March 15, 2020

Job Description:

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

The Quality Control Lead Analyst (2nd Shift) is responsible for routine QC testing on cleaning, in-process and release samples. The QC Lead Analyst will also assist analytical method transfers and method qualifications between the Analytical Development group and Quality Control (QC). This individual will be responsible for assisting with the monitoring of the day to day operations within the QC laboratory. The QC Lead Analyst must demonstrate strong technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.

This is a second shift position that will reside roughly on a 4pm-12am schedule and will report to the QC Supervisor at our Harmans/BWI site.

Paragon Gene Therapy, now a part of Catalent, 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/Job Duties:

--- Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, ddPCR, HPLC, Capillary Electrophoresis, and Compendia.
--- Generate internal and external documents such as assay protocols, summary reports, and SOPs.
--- Work with clients during initial and subsequent transfer of assays and analytical methods to support GMP manufacturing campaigns.
--- Provide instrumentation care, maintenance, troubleshooting, and data interpretation.
--- Work on project teams developing and improving assays.
--- Work under general supervision to meet project goals.
--- Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility and products manufactured.
--- Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.

The Candidate

Experience & Education:

--- Bachelor in a Life Sciences discipline and 6 or more years of experience working in a QC laboratory (will consider reduced experience with increased levels of education in same field).
--- Team lead or leadership experience.
--- Considerable knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology.
--- Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/QC function with a strong familiarity of general GMP practices.
--- Experience in writing SOPs and test methods as well as method qualification/validation documentation.
--- Broad experience with biochemistry and biological assay support, as well as generating/reviewing the documentation that supports such work.
--- Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks.
--- Ability to succeed in a team-oriented environment under very dynamic conditions.

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:

--- Join a high growth and fast paced organization with a people focused culture
--- Global exposure, defined career path and annual performance review and feedback process
--- Competitive Medical, Dental, Vision and 401K

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 www.catalent.com/careers to explore career opportunities.

Catalent 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.

Keywords: Catalent, Severn , Quality Control Lead Analyst (2nd Shift), Professions , Severn, Maryland

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Professions Jobs


Truck Driver CDL A
Description: CDL A Truck Driver - Regional - Earn Up to 1,300/Week Get Home Weekly At Dart, we reward excellence. That means the more miles you put in, the more we scale your pay rate up. Join our team today and (more...)
Company: Dart Transit Company
Location: Harrisburg
Posted on: 03/29/2020

CDL-A Company Team Truck Driver
Description: CDL-A TEAM TRUCK DRIVER JOBS DOUBLE YOUR EARNINGS AT USA TRUCK br br Double your earning power with NEW PAY for truck driving teams br br USA Truck, a Certified Top Pay Carrier, is proud to announce (more...)
Company: USA Truck
Location: Bowie
Posted on: 03/29/2020

2020 Fall Supply Chain/Engineering Co-op
Description: Caring for the world, one person at a time has inspired and united the people of Johnson Johnson for over 130 years. We embrace research and science,--bringing innovative ideas, products and services (more...)
Company: Johnson & Johnson
Location: Lancaster
Posted on: 03/29/2020


Class A Owner Operator - Teams
Description: br br Over the Road: Team Owner Operators The foundation product for Forward Air is our over-the-road LTL service. In LTL you will run our trailers no trailer fees , drop hook from one Forward (more...)
Company: Forward Air
Location: Harrisburg
Posted on: 03/29/2020

Class A CDL Driver - Home Daily
Description: Company Profile: br We are a locally owned and operated business since 2006 and we are in need of a CDL A Driver.
Company: Allen Enterprises / Allen Trucking
Location: Lancaster
Posted on: 03/29/2020

Truck Driver Class A CDL Recent Grads - Better Pay!
Description: Recent CDL-A Grads: Don't have enough experience to get the truck driving job you want No worries, come join us You will spend 165 hours behind the wheel with
Company: C.R. England
Location: Chantilly
Posted on: 03/29/2020

CDL-A Truck Driver
Description: 80 OF DRIVERS SEATED IN 3 DAYS - SIGN ON BONUS AVAILABLE IN CERTAIN LOCATIONS br
Company: U.S. Xpress
Location: Harrisburg
Posted on: 03/29/2020

Company Truck Driver - CDL-A
Description: CDL-A COMPANY TRUCK DRIVER JOBS br br Save For Your Future With J R Schugel Enjoy NEW OTR PAY br br Join the carrier who puts drivers first: J R Schugel. As a 100 employee-owned company, J (more...)
Company: J & R Schugel
Location: Bowie
Posted on: 03/29/2020

New CDL A routes with US Logistics
Description: br br CDL A routes with US Logistics 75k - 80K Annually Fantastic equipment br br Openings available in the following locations: br ul li Pennsylvania: br ul li Lake Harmony, (more...)
Company: US Logistics
Location: Harrisburg
Posted on: 03/29/2020

CDL-A OTR COMPANY TRUCK DRIVER JOBS UP TO .50 CPM
Description: Call and speak to a recruiter to learn more 866 517-4179 br br br CDL-A OTR COMPANY TRUCK DRIVER JOBS UP TO .50 CPM br br 8232 8232 Founded in 1937 as a family-owned and operated transportation (more...)
Company: Paschall Truck Lines
Location: Harrisburg
Posted on: 03/29/2020

Log In or Create An Account

Get the latest Maryland jobs by following @recnetMD on Twitter!

Severn RSS job feeds