Senior Manager QC & Testing - #252738

Description

Position Summary: Under supervision of VP Quality, Regulatory & Compliance, the Senior 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.

Essential Duties And 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)
  
  

Competencies

Achievement Focus - Demonstrates persistence and overcomes obstacles. Measures self against standard of excellence. Recognizes and acts on opportunities. Sets and achieves challenging goals. Takes calculated risks to accomplish goals.

Communications - Exhibits good listening and comprehension. Expresses ideas and thoughts in written form. Expresses ideas and thoughts verbally. Keeps others adequately informed. Selects and uses appropriate communication methods.

Managing Customer Focus - Develops new approaches to meeting internal and external customer needs. Establishes customer service standards. Monitors customer satisfaction. Promotes customer focus.

Managing People - Develops subordinates' skills and encourages growth. Includes subordinates in

planning. Makes self-available to subordinates. Provides direction and gains compliance. Provide

regular performance feedback. Takes responsibility for subordinates' activities.

Planning and Organization - Integrates changes smoothly. Plans for additional resources. Priorities and plans for work activities. Set goals and objectives. Uses time efficiently. Works in an organized manner.

Problem Solving - Develops alternative solutions. Gathers and analyzes information skillfully. Identifies problems in a timely manner. Resolves problems in early stages. Works well in group problem solving situations.

Qualifications

Essential Skills and Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Microbiology, or a related scientific field. A minimum of 3 years of progressive experience in analytical testing and quality control within a relevant industry. An equivalent combination of education and experience may be considered.
• Excellent written and verbal communication skills, including the ability to effectively present information to diverse audiences (managers, customers, and the public) and to write clear and concise reports, business correspondence, and procedure manuals. Must be fluent in English.
• Strong foundational mathematical skills, including the ability to work with fractions, decimals, percentages, ratios, and time calculations.
• Demonstrated proficiency in analytical testing methodologies, including hands-on experience with instrumentation such as HPLC, FTIR, UV-Vis, and GC.
• Proven ability to develop and validate analytical methods in accordance with industry standards and regulatory requirements.
• Experience performing microbiological testing, with a preference for candidates with experience in rapid microbiological methods.
• Expert-level scientific and technical writing skills, including the ability to independently create and review Standard Operating Procedures (SOPs), technical reports, and validation protocols.
• Experience in the planning and incorporation of microbiology and/or analytical testing facilities is highly desirable.
• Demonstrated ability to solve practical problems, interpret complex instructions, and work effectively in situations with limited standardization.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Previous experience in management or supervisory role is a significant plus.
  
  
  

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.The noise level in the work environment is usually moderate.

Physical Demands

Standing for prolonged periods of time. Lifting up to 25 pounds may be required.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.