Sr. Specialist, Quality Assurance, Sample Management at PTC Therapeutics, Inc. in Pennington, New Jersey

Job Description:

Job Description Summary:

The Senior Specialist, Quality Assurance, Sample Management – will support the on-going enhancement of the PTC quality system by actively maintaining the compliance of GMP sample management program.

This position supports the start-up and future activities for Gene Therapy manufacturing and requires close collaboration with Manufacturing, Quality Control (QC), Analytical Development, and Information Technology (IT).

This individual is responsible for supporting the implementation and application of a Laboratory Information Management System (LIMS), as it applies to Sample Management.

This individual is also responsible for sample receiving, distribution, and aliquoting (as needed), as required for various raw material, manufacturing, and laboratory sample requests.

The incumbent works cross-functionally with internal departments and external resources on sample management program-related issues.

The Senior Specialist, Quality Assurance, Sample Management supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Description:

Responsibilities:

• Sample management responsibilities via LIMS:
  Coordination of sample receipt, logging, labelling, and distribution via Laboratory Information Management System (LIMS) workflows.
  Sample allocation in LIMS and collaboration with and end users/stakeholders (upstream/downstream, QC, etc.) to understand business processes in place to ensure continuity.
   


• Sample receipt, storage, distribution, and shipment:
  Responsible for packaging and shipment of samples to contract testing laboratories.
  Ensure all samples are shipped and received according to proper procedure.
  Management of receipt, tracking, and chain of custody of internal samples.
  Assist with storage, pulls, and distribution of stability samples, as needed.
  Ensure proper temporary/short-term storage of testing samples and follow proper procedures to maintain proper storage requirements.
  Perform storage inventory audits and troubleshoot with stakeholders as needed.
  Ensure samples are distributed to appropriated laboratory personnel/departments, as required.

• Sample aliquoting:
  Performs aliquoting procedures on specified samples to produce aliquots as required for internal and external laboratory testing.
  Receive bulk samples from manufacturing and then aliquot samples to be distributed to the laboratory for testing.

• Update / Revise / Author Sample Management related forms and/or SOP’s, as needed, to reflect current processes.

• Collaborate with other departments on the management of reference standards, reserve samples, and retain samples.

• Performs other tasks and assignments as needed and specified by management. 

Qualifications:

• Bachelor’s degree in a relevant scientific discipline and a minimum 3 years of experience in a Quality Assurance, Quality Control, Analytical or related role(s) in a pharmaceutical, biotechnology or related environment.


• Previous experience in a laboratory-based role (sample aliquoting experience a plus).


• Demonstrated understanding of sample control and chain of custody tracking.


• Experience with LabVantage LIMS or other LIMS software.


• Knowledge and understanding of GxP regulations.


• Proficiency with Microsoft Office.


• Excellent verbal and written communication and skills.


• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.


• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. 


• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. 


• Demonstrated understanding of daily sample planning on the manufacturing floor and sample scheduling within the laboratory preferred.


• Experience with SAP preferred.


• Experience in Quality Management Systems including Deviation Management, Out of Specifications, Change Control preferred.


• Experience with stability program requirements preferred.


• Detailed/Demonstrated knowledge and understanding of Health Authority requirements preferred.


• Travel requirements: 0-15%


• Laboratory-based position. Requires light physical activity (e.g., transporting samples and supplies between buildings and laboratories.)

**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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