Supervisor, Quality Control - Analytical Chemistry

Location
Harmans, MD, US
Posted
May 26, 2019
Ref
1389
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Paragon Bioservices, Inc. (PBI) is a growing bio-pharmaceutical 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 clinical trials through GMP Commercial Production 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 position is responsible for effectively hiring, developing, coaching, counseling, managing and motivating the QC analytical staff. They are responsible for the timely and accurate completion of required analytical testing of raw materials, in-process and finished products and stability samples. They assure compliance to GMP and company specifications as well as relevant pharmacopeia compendia. The supervisor identifies areas for continuous improvement and/or implementation of industry best practices and drive implementation in the laboratory. The supervisor keeps laboratory management informed of all departmental activities and product related events.

Key responsibilities include but are not limited to:

  • Supervises the daily activities of QC analytical staff and assures that job activity deadlines are met on a timely basis.
  • Generate, review and approve internal and external documents such as assay protocols, summary reports, STMs and SOPs
  • Work with clients during initial and subsequent transfer of assays and analytical methods to support GMP manufacturing campaigns
  • Direct supervision of laboratory staff including degreed chemists as well as additional laboratory support staff
  • Hires and oversees the training of QC department personnel. Assures that steps are taken to maintain positive personnel morale and development
  • Ensures that raw materials, components, products, or monitoring results that do not meet specifications or expectations are promptly investigated. Identifies possible source and corrective action needed and evaluates the impact upon the product
  • Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending
  • Reviews work performed by department staff for accuracy, completeness and conformance to GDP and product specifications
  • Mentors and develops new department personnel including training in Standard Operating Procedures and On The Job Training (OJT)
  • Assures department is equipped with functional, calibrated equipment and necessary supplies
  • Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, and Laboratory Investigation Reports
  • Represents the QC Microbiology department in cross functional teams and internal/external meetings
  • Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility and products manufactured
  • Troubleshooting laboratory instrumentation issues
  • Providing back up assistance in performing laboratory testing as needed
  • Assumes other duties and responsibilities as assigned

Experience & Education:

  • Bachelor degree in a chemistry or life science field
  • 8 years experience working in a GMP Quality Control role with 2 years of supervisory experience
  • Experience with cell based assays such as ELISA, DNA/RNA extraction, gel electrophoresis, qPCR, RT-PCR, HPLC and Capillary Electrophoresis
  • Experience with Microsoft Office and Excel
  • Have the knowledge and ability to apply advanced scientific and regulatory principles to solve operational, as well as routine quality tasks.
  • Strong focus on responsiveness, ability to multi-task, attention to detail, consistent follow-up and ability to make timely and sound decisions (Quality and Business). Must be able to prioritize.
  • Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels

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.

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