Quality Control Sample Coordinator
- Employer
- Paragon Gene Therapy, a unit of Catalent Biologics
- Location
- Harmans, MD, US
- Start date
- Apr 14, 2019
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- Discipline
- Clinical, Clinical Project Management, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioCapital
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Job Details
Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
Key Responsibilities include but are not limited to:
Experience & Education:
Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
#LI-EW1
Key Responsibilities include but are not limited to:
- Sampling of raw materials according to established specifications
- Sample coordination and receipt from other departments for internal and external testing
- Scheduling of QC testing and activities
- Sending out of test samples to Contract Testing Laboratories (CTL)
- Follows up with CTLs on testing and turnaround times to ensure testing deadlines are met
- Trending of all CTL test results
- Works closely with Manufacturing, Analytical Development and Process Development for scheduling of samples submission to the QC lab. May also interact with Project Managers on sample coordination
- Effectively communicates updates and results from CTLs
- Flexibility in following unique campaign requirements that may include off-hour and weekend work
- Other duties as assigned
Experience & Education:
- High School Diploma and 1-2 years of experience working in a cGMP environment required. Biologic sample coordination preferred
- Experience with Microsoft Excel and Microsoft Word
- Strong attention to detail and strong organizational skills
- Strong verbal communication skills with outside contract laboratories
- Ability to succeed in a team-oriented environment under very dynamic conditions
Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
#LI-EW1
Company
Company info
- Location
-
801 West Baltimore Street
Suite 302
Baltimore
Maryland
21201
US
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