Lab Technical Supervisor

The Technical supervisor is mainly responsible for leading and support various laboratory functions such as out of spec investigations, process improvement and technical writing which includes creating and maintaining standard operating procedures and providing support to the lab operations. This position will also support new product development and the Compliance team as research and various tasks arise including reviewing validation documents and supporting FDA projects. This position will also interface with and provide support to the Research and Development team and the Science Board Team.

Specific Job Duties:

1.Ensure QC lab compliance with GMP, GLP, and internal SOPs.

2.Manage instrument qualification, calibration, and maintenance programs.

3.Critical strategic contributor, leading high impact research initiatives for the Scientific Board and partnering closely with R&D teams to resolve complex technical challenges

4.Lead OOS/OOT investigations; implement CAPA and effectiveness checks.

5.Support audits and regulatory inspections; prepare documentation and responses, especially those supporting FDA, UL and any Kaizen activities.

6.Review and approve analytical data and Certificates of Analysis (CoAs).

7.Review/analyze and approved FDA reports (key)

8.Support LIMS operations.

9.Run Safety & onboarding training; maintain records and retraining triggers.

10.Lead and manage LAII team for OSI process improvement, documentation, compliance.

11.Redesign/manage OSI program (oversight of OOS/OOT investigations, trending).

12.Run/facilitate the MRB mtg and lead lab investigations for MRB agenda items.

13.Own/coordinate compliance, data integrity, and process optimization projects.

14.Draft/update SOPs, work instructions, and controlled forms, coordinate approvals.

15.Statistically analyze quality data and identify potential problem areas to prevent issues.

16.Perform all other tasks assigned by Threshold management.