QC Associate II Contractor at Sarepta Therapeutics in andover, Massachusetts

Job Description:

This individual will support quality control activities conducted both internally and at the Contract Test Laboratories (CTLs). The individual will be responsible for reviewing release and stability data, writing technical reports, supporting analytical method validation and qualification activities conducted at the CTLs. This individual will assist in transferring assays to and from domestic and overseas vendors and monitoring, compiling and reviewing data. The individual will also assist in managing quality events, data trending, review of quality documents originated at the testing laboratories as well as internally at Sarepta. All aspects of this position would involve working in a GMP compliant manner.

Primary Responsibilities Include:

• Review LC, LC/MS, GC, KF and other general laboratory data generated per cGMP for release and stability samples.


• Assist in writing and reviewing quality documents such as test methods, SOP, OOS/OOT and CAPA originated internally as well as at the vendor sites.


• Assist in transferring assays to and from vendor sites and their troubleshooting.


• Monitor, review and trending of stability data.


• Manage activities related to reference standard qualification and supply to external sites.


• Assist in writing validation protocols, reviewing validation reports for LC, LC/MS, GC and other analytical methods.


• Execution of laboratory experiments, review of analytical data and authorization of final reports.

Education and Skills Requirement:

• MS with 1-2 years or BS with 3-5 years in Chemistry or related science field. With appropriate experience this requirement may be waived.


• 3-5 years in a QC release of DS and DP and conducting stability studies in a cGMP environment is preferred.


• Experience with laboratory equipment operation namely HPLC, GC, LC-MS, KF, pH and an understanding of CCIT, Microbiological testing.


• Attention to details is a must.


• Strong organizational skills.


• Effective written and verbal communication skills.


• Operate independently or as a part of a team, experience training individuals in a laboratory environment.


• Experience in working with contract test lab is highly desired.


• Position may require some travel.


• Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion.

Candidates must be authorized to work in the U.S.

Sarepta offers a competitive compensation and benefit package.

Sarepta is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.