Quality Supervisor at EKF DIAGNOSTICS INC – Sound Bend, Indiana

SUMMARY OF POSITION:

The working Quality Supervisor is a hands-on role within the Compliance Department, responsible for daily oversight of both Quality Assurance (QA) and Quality Control (QC) activities within a fermentation/enzyme manufacturing environment, including contract manufacturing operations. This role combines frontline execution with supervisory responsibilities, ensuring that quality systems, testing, documentation, and production support activities are carried out accurately, efficiently, and in compliance with regulatory, quality and customer requirements.

ESSENTIAL FUNCTIONS, included but not limited to:

• Support the overall Quality System, including audits, Corrective and Preventive Actions (CAPAs), Non-Conformance Reports (NCRs), Planned Deviations, document control, risk management, and continuous improvement activities, etc.
• Supervise and prioritize daily QA and QC functions, ensuring timely completion of testing, batch record review, including release activities, and deviation management, etc.
• Actively participate in laboratory, testing, calibration, process improvements, and documentation, etc.
• Participate in customer, certification and regulatory audits
• Perform product release functions, including review of batch records, test results, and supporting documentation.
• Assist in SOP revisions and implementation of updated quality procedures.
• Contribute and/or lead to continuous improvement initiatives, including process mapping, risk assessments, and efficiency projects.
• Monitor the customer complaint handling process through review and approval of completed complaint investigations.
• Support maintenance of the annual internal audit schedule and ensure internal auditors receive required training.
• Act as a supportive site representative for quality-related matters, ensuring alignment between compliance (QA/QC) and Operations.
• Provide hands-on support in the QC laboratory, including wet chemistry, enzymatic assays, spectrophotometric testing, environmental monitoring, and other routine analyses as needed.
• Support as a on-floor quality presence during fermentation / contract manufacturing operations, as needed
• Partner with Operations to troubleshoot quality-related issues in real time, including fermentation parameters, enzyme activity, contamination risks, and in-process control failures.
• Support and/or lead investigations into nonconformances, OOS results, and process deviations; drive root cause analysis and corrective/preventive actions.
• Foster a collaborative, solutions-focused culture that supports continuous improvement and cross-functional communication.
• Adhere to current Good Manufacturing Practices(cGMP).
• Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc.

OTHER FUNCTIONS:

• Ensure compliance with safety regulations and procedures are implemented and followed; Maintain clean and safe work area.
• Assist as needed in other areas of the company where training requirements are identified.
• Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

• Supervise the Quality Control and Quality Assurance personnel at the South Bend site.
• Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws; Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; coaching and counseling employees; addressing complaints and resolving problems.

TRAVEL:

• None

REQUIRED QUALIFICATIONS:

• Legally authorized to work in the United States.
• Bachelor's degree (B.A. /B.S.) from an accredited college or university in a technical, scientific, or related field.
• Three (3) years of experience in quality assurance working within and supporting a quality management system.
• Two (2) years of supervisory experience
• Technical knowledge of fermentation and bioprocesses.
• Strong knowledge of various standards and regulations such as ISO 9001, ISO 13485:2016, ISO 14971, the Quality Management System Regulation (21 CFR Part 820)
• Ability to interpret and apply regulatory requirements.
• Proven ability to translate complex technical concepts into clear, concise, and user-friendly documentation for both technical and non-technical audiences.
• Strong analytical mindset with a track record of identifying trends and translating findings into comprehensive reports, process maps, and standard operating procedures (SOPs).
• Demonstrated expertise in rigorous root-cause analysis and the production of high-quality technical documentation, ensuring accuracy and knowledge retention across the organization

PREFERRED QUALIFICATIONS:

• Familiarity with products similar to EKF Life Sciences .
• Previous experience working at a Contract Manufacturing Organization (CMO)/Contract Development and Manufacturing Organization (CDMO).

BASIC SKILLS AND ABILITIES:

• Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
• Good computer skills including Microsoft Word, Excel, Outlook.
• Detail oriented with a high level of accuracy, efficiency, and accountability.
• Excellent organizational skills to meet goals and set priorities.
• Proven ability to handle multiple priorities and meet deadlines; work in a fast-paced environment.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Ability to work independently and as a member of various teams and committees.
• Good coaching, mentoring and leadership skills; able to provide constructive feedback that develops employees and their long-term contributions to EKF Diagnostics.

REASONING ABILITIES:

• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Must have strong analytical and planning skills sufficient to determine resources and time required to complete projects.

LANGUAGE SKILLS:

• Good written and oral communication skills; with the ability to interface well with management, internal employees, FDA, notified bodies, and other international regulatory authorities.
• Ability to read, analyze, and interpret general business periodicals, professional scientific and technical journals, technical procedures, and governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.

MATHEMATICAL SKILLS:

• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

VISUAL ACUITY:

• Close visual acuity to perform an activity such as preparing and analyzing data, transcribing, viewing a computer terminal, and reading.

PHYSICAL DEMANDS:

• Must be able to wear and work in personnel protective equipment (PPE) as required.
• Light physical activity performing non-strenuous daily activities or a primarily administrative nature.
• Stationary position sitting for long periods of time while utilizing standard office tools.
• Constant repetitive motions that may include the wrists, hands and/or fingers to operate keyboard and mouse; dexterity and coordination necessary to handle files and single pieces of paper.
• The ability to hear, understand, and distinguish speech.
• Frequently communicate information and ideas with others to exchange information and understanding. Able to exchange accurate information in these situations.
• Frequently lift and/or move up to 10 pounds.
• Occasionally reaching for items above or below desk level.
• Occasionally required to climb or balance; squat, stoop, kneel, crouch, or crawl; and smell.

ENVIRONMENT CONDITIONS:

• Well lit, heated/air-conditioned indoor office setting with adequate ventilation.
• The noise level in the work environment is low.
• Periodic exposure to low temperatures in controlled refrigerators and/or freezers.
• Exposure to hazards or physical risks which require following basic safety precautions