A Clinical Laboratory Manager manages laboratory research and procedures for numerous fields such as health, industry, or other natural sciences. Commonly oversees R&D, diagnostic or treatment to allow patients to receive better health outcomes. Responsible for regulatory, health and safety operations during laboratory activities.
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.
Minimum Qualifications Required :
1.B.S. degree in Food Science, Food Safety, Chemistry, Microbiology, Biology or related technical field with 4 years of experience or equivalent. 2.Demonstrated knowledge of quality systems such as GMP, GLP, HACCP, or ISO, including laboratory compliance, auditing, or microbiology. 3.4+ years of experience Supervising, Managing or Developing Others or project management skills.
Preferred education and experience:
1.In depth knowledge of GMP and GLP for dietary supplements. 2.4+ years in the dietary supplement industry and / or related industry 3.5+ years of supervisory / management experience Skills and/or
Training Desired:
1.Strong Knowledge of and/or experience with one or more quality systems such as
GMP, GLP.
HACCP, or ISO including Laboratory compliance, Auditing, or Microbiology OR an equivalent combination of education, training, and experience. 2.Proficiency in OOS investigations, root cause analysis, CAPA development and documentation. 3.Skilled at SOP writing, training program development, coaching analysts and maintaining audit ready documentation. 4.Experience with LIMS system and electronic data workflows. Apply statistical data analysis and process improvement. 5.Strong communications skills, both written and oral, to effectively implement and facilitate new ideas, processes, and programs. 6.Project management skills
