Second Shift Materials Control Associate
Paragon BioServices, Inc.
Harmans, Maryland, United States
Job type: fulltime
Job industry: Other
Paragon Bioservices, Inc. (PBI) is a growing biopharmaceutical contract development and manufacturing organization with an internationally recognized tradition of quality and service. PBI 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.
This role is responsible for supporting the overall GMP materials control/warehousing operations for a Phase II/II GMP biopharma manufacturing facility. The position requires practical experience and knowledge of a variety of activities such as materials receipt/quarantine/release, logistical support in a manufacturing facility, electronic inventory control and distribution/shipping of products.
Hours are 4:00 PM - 12:00 AM
Responsibilities include but are not limited to:
- Conducts reviews of GMP documentation associated with materials control (material specifications, receipt inspection forms, inventory records, item request form)
- Assessing the Materials Control operation on a continuing basis and providing recommendations for improvement is encouraged
- Generation of GMP documentation (SOPs, etc.) is expected
- Will participate in the receipt of all GMP materials - rectify discrepancies, matching vendors' documentation against Paragon requirements (GMP and accounting). Initiates appropriate documentation in a timely manner
- Will distribute materials for GMP operations following approved procedures. This includes assisting in the reconciliation of all GMP materials after client campaigns
- Compile and maintain inventory records
- Takes receipt and inventory control of Paragon generated material (cell banks, bulk protein, etc.)
- Assists with performing internal audits
- Will participate in regulatory (FDA, EMEA) and client audits/inspections of Paragon and the facility
- Works under general supervision to meet project goals
- Works closely with QA to quarantine and release all GMP materials in a timely manner
- Participation in the organization and cleanliness of the warehouse will be critical
- Assists in the training of "junior" personnel
- Will work closely with various departments at Paragon and aid as needed. This may include support for pre-clinical projects
- Working closely with various departments and aids as needed
Experience & Education:
- High School Diploma with at least 2 years of relevant experience with warehousing operations
- Experience with electronic inventory control systems as well as MS Outlook and Excel
- Documented training (certification) of hazardous materials
- Mature professional capable of independent work
- Ability to lift and carry up to 40 lbs. is required
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.