Sr. QC Technical Specialist

The Sr. QC Technical Specialist is a critical member of the QC team. He/she is responsible providing quality and technical support to the QC Analysts and QC Leads and Leaders. He/she is responsible for ensuring compliance in the laboratory in accordance with cGMPs, international regulations and Spark procedures. The Sr. QC Technical Specialist will be responsible for:

• Meet and driving changes to ensure technical support needs are met, including schedule adherence and right the first time execution of testing. 

• Providing guidance for necessary analytical changes in partnership with Analytical Sciences and QC Leads and Leaders.

• Supporting Spark QC key projects aimed at elevating the compliance and performance of the QC laboratory.

• Reviewing documentation generated by Spark QC and Contract Testing Laboratories (CTL) for accuracy and GDP, as assigned by Functional Management

• Generating  and review SOP’s, Technical Documents, Technical Protocols and Reports for the Technical Operations team.

• Performing non-conformance (OOT/OOS) investigations, CAPAs, and change controls associated with both insourced and outsourced testing.

• Supporting Spark QC in regulatory inspections.

Responsibilities

40%

• Perform complex QC testing, particularly cell-based assays, to support clinical and commercial product release

• Provide real-time technical support to the QC Analysts

• Support management of daily operations of Quality Control Biochemistry group (self-inspection program, Laboratory logbook review, …)

• Schedule testing for Quality Control Biochemistry group according to Department and Company priorities.

40%

• Assist the QC Compliance Lead and generate policies, procedures and Technical Protocols/Reports related to QC testing.

• Assist the QC Compliance Lead with Data Review.

• Act a Lead Investigator in Deviation/Investigations and OOS/OOT Investigations.

• Support management of QC equipment and instrument in collaboration with QC Stability & Systems and Facilities.

15%

• Support and review of regulatory submissions.  

• Support Spark during audits and regulatory submissions.

5%

• Routine support of Technical Operations (Manufacturing, MS&T, Facilities) as assigned by Functional Management

Qualifications

• High attention to details; ability to identify errors and incompleteness of lab generated documents;

• Proven extensive technical writing experience with the ability to provide work examples of such experience; 

• Proven analytical aptitude, critical thinking skills and ability to apply key concepts;

• Proven ability to manage multiple tasks/projects simultaneously;

• Ability to work independently and manage work to defined schedules;

• Team work spirit and excellent people skills;

• In-depth understanding of biological and molecular assays

Requirements

• BS or MS degree required in relevant scientific discipline (such as molecular biology, biochemistry or virology);

• For candidates with a Bachelor’s degree, a minimum of 7 years of experience in a GMP environment is required, including hands-on experience in cell-based assay and qPCR assay development;

• For candidates with a Master’s degree, a minimum of 5 years of experience in a GMP environment is required including hands-on experience in cell-based assay and qPCR assay development;

• Experience in QC or QA review of lab generated records and data within the pharmaceutical/regulated industry;

• Experience in pharmaceutical laboratory operations or related environment;

• In-depth working knowledge and application of cGMPs and regulatory guidance; 

• Excellent written and verbal communication skills.