Swiss American CDMO · 4 weeks ago
Manager of Internal Testing
Carrollton, TX
Full-time
Onsite
Mid, Senior Level
2+ years expSwiss American CDMO is a high-growth company seeking a Manager of Internal Testing to oversee the QC laboratory operations. The role involves managing personnel, ensuring compliance with regulatory standards, and leading investigations into quality issues while developing performance metrics for quality control.
Consumer GoodsManufacturing
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)
Qualification
Required
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)
Preferred
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
Company
Swiss American CDMO
Swiss American CDMO is a developer and manufacturer of topical skin and wound care products.
201-500 employees
H1B Sponsorship
Swiss American CDMO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
Funding
Current Stage
Growth StageLeadership Team
Komel Grover
President & CEO
Company data provided by crunchbase