Manager of Internal Testing

Swiss American CDMO•Carrollton, TX

4h•Onsite

About The Position

Under supervision of VP Quality, Regulatory & Compliance, the Manager QC & Testing will be responsible for managing the personnel responsible for responsible for day-to-day operations of a microbial and analytical QC laboratory in a high-growth, fast-paced work environment while ensuring compliance with cGMP/cGLP guidelines and company SOPs. They will also be the point person for any external third-party laboratories used.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Microbiology, or a related scientific field.
Minimum of 2 years of hands-on experience in analytical testing and quality control.
Equivalent combinations of education and experience may be considered.
Proficiency in analytical instrumentation: HPLC, FTIR, UV-Vis, GC.
Strong understanding of analytical testing methodologies.
Solid mathematical skills (fractions, decimals, percentages, ratios, time).
Excellent written and verbal communication skills.
Ability to write clear reports, SOPs, and technical documentation.
Fluency in English.
Ability to interpret complex instructions and solve practical problems.
Comfortable working in environments with limited standardization.
Digital Literacy
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).

Nice To Haves

Experience developing and validating analytical methods per regulatory standards.
Exposure to microbiological testing, especially rapid microbiological methods.
Familiarity with GMP, GLP, or ISO standards.
Prior experience in a supervisory or managerial role.
Ability to lead cross-functional teams and mentor junior staff.
Involvement in the design or setup of microbiology or analytical testing labs.
Experience managing lab expansions, equipment procurement, or facility compliance.
Expert-level technical writing for SOPs, validation protocols, and regulatory submissions.
Experience with audits or regulatory inspections (e.g., FDA, EMA, ISO).
Strong interpersonal skills and ability to communicate with cross-functional teams.
Adaptability in fast-paced or evolving environments.

Responsibilities

Participate in investigations for process deviations and product quality failures and assist in implementation of corrective actions.
Develop and determine implementation strategy for quality key performance indicators (KPI’s).
Track and trend progress on all KPIs, and report to VP. If necessary, be able to report the findings to ELT and for periodic reviews.
Investigate CAPA’s audit findings to ensure that adequate measures are put in place to prevent reoccurrence of CAPA causing activities
Includes determining a corrective action plan and the implementation of the corrective action
Troubleshoot and resolve testing related issues
Reviews change controls to determine activities needed as per regulations and Swiss American procedures.
Serves as the authority for Quality Control related issues in the production of bulk and finished goods.
Manage the day-to-day in-house microbial and analytical testing
Perform microbial testing on raw materials, in-process and finished goods as required
Perform analytical testing using instruments such as HPLC, FTIR, UV-Vis, GC
Investigate OOS found during testing both internally and from external laboratories
Perform qualification of new laboratory equipment and re-qualification of existing laboratory equipment
Lead analytical method development and validation for new formulas
Lead micro suitability for all new formulas
Schedule and verify the maintenance/calibration of all testing laboratory instruments
Ensure that all testing is performed in accordance with SOPs, FDA and cGMP/cGLP guidelines
Troubleshoot and resolve testing instrumentation related issues
Develop and manage a team of 1-5 technicians and ensure all personnel are appropriately trained and qualified to perform relevant tasks
Interact with Regulatory Authorities and clients during inspections/audits
Liaise with third party external laboratories (primary contact)