Job Title: Quality Control Laboratory Lead

Employment Status: Full-Time

Classification: Non-Exempt

Work Schedule: Monday-Thursday 4:00pm – 2:00 am, ability to work overtime as needed.

Reports to: Quality Control Supervisor

Supervisory Responsibilities: No

Pay: $22.00 to $24.00/hour

Position Summary: Quality Control (QC) Laboratory Lead is responsible for accurately testing and approving incoming raw materials and manufactured products according to standard procedures and specifications.  Ensures quality through testing and inspection at various stages of the production process; compiles and evaluates statistical data to determine and maintain quality.  The QC Laboratory Lead is responsible for coordinating shift activities and performing supervisory roles when appropriate.

Essential Functions:

• Works with the Quality Control Supervisor to ensure that all required tasks are adequately explained to personnel and completed in a timely manner. Acts in a daily laboratory coordination and leadership role. Trains new and existing employees on tasks and coordinates responsibilities.
• Obtains and disseminates pertinent information to laboratory peers when required through attendance of meetings and professional development opportunities.
• Performs quality control tests on raw materials and manufactured products in a timely and accurate manner per established guidelines and frequencies.
• Conducts First Piece Inspection quality control tests and inspections on device production.
• Collects samples including raw materials, validation, in-process, and finished product samples for analytical testing.
• Ensures the QC support of Environmental Monitoring in Manufacturing along with verification and validation of cleaning processes.
• Calibration, cleaning, and maintenance of laboratory equipment and instruments.
• Maintains laboratory inventory along with contributing to laboratory cleanliness and biohazard removal.
• Provides additional troubleshooting capability, assesses, and corrects common laboratory problems with limited assistance.
• Releases product in a timely manner and generates certificate of analysis/conformance as needed.
• Performs in-process audits throughout the course of the shift to verify compliance to both internal procedures and customer specifications.
• Follows established health and safety procedures and policies.

Other Duties

• Assists with validations, studies, and routine tests required for product development.
• Assists and coordinates with submission of samples sent to external laboratory for testing.
• Assists in Out of Specification investigations, root cause analysis, and corrective action development.
• Participates in documentation updates and reviews as needed.
• Performs other Quality Control Lead duties as assigned.

This is not meant to be a comprehensive listing of activities, duties, and responsibilities. These items may change, or new items may be assigned with or without notice.

Experience and Education Requirements

• High School Diploma or equivalent required
• Bachelor’s Degree, Chemistry, Biology, or Microbiology preferred.
• Analytical Lab, Quality Control Lab, or Manufacturing experience required.
• Three plus years of experience preferred, but not required.

Knowledge, Skills, and Abilities (KSA’s) Required

• Knowledge of the proper use and preparation of chemicals and reagents.
• Strong working knowledge of various mathematical concepts including fractions, ratios, and proportions.
• Knowledge of Food Safety, Pharmacopeia’s and/or Regulatory requirements.
• Knowledge of laboratory equipment operation, troubleshooting, and maintenance.
• Knowledge of effective and safe laboratory and experimental procedures.
• Excellent verbal and written communication skills.
• Excellent interpersonal, negotiation, conflict resolution, and people skills.
• Strong analytical and problem-solving skills are required.
• Excellent time management skills with a proven ability to meet deadlines.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to self-motivate and work without direct supervision.
• Ability to lead and motivate staff.
• Ability to perform laboratory tasks such as pipetting and measuring using a caliper.
• Ability to use Microsoft Office, other computer programs, and technology.

Physical Requirements

The physical demands listed are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. Modified “light duty” restrictions may be arranged as needed and when available for job-related injuries or illnesses.

While performing the duties of this job, the employee is regularly required to walk on normal surfaces, stand, and sit; use hands for writing and keyboarding.  The employee is occasionally required to lift, carry, and/or push up to 5-10 lbs., stand, stoop, and bend, walk on uneven surfaces, and reach/stretch.  Specific vision abilities required by this job include visual acuity sufficient to read a computer screen and paper documents.  Acute hearing is necessary for phone and in-person communication with fellow employees and other contacts.

Working Conditions

This position typically functions in office, lab, and warehouse/production areas.  There will be exposure to moderate noise levels, fumes, dust, chemicals, heat/cold, and allergens especially in the warehouse, lab, and production environments.

EEO Policy Statement:

Gusmer Enterprises, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Gusmer will also consider requests for reasonable accommodations made by applicants and employees on an individualized basis, including those based on disabilities and sincerely held religious beliefs, where such accommodations do not impose an undue burden on the business. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.