The position is primarily responsible for assisting the Company’s execution of all Quality initiatives, maintaining, and assisting with furthering the development of the quality program. Eliminate defects in new or existing products by performing the following duties.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Core duties and responsibilities include the following. Other duties may be assigned.
- Analyzes products in compliance with cGMP regulations and SOP.
- Perform quality tests throughout all stages of production such as but not limited to oxygen, brew, burst, weight, and organoleptic testing.
- Completes online startups to verify all materials for a given work order are correct and present.
- Validates production of new items by confirming work order is correct and complete, performing online startup and quality tests.
- Performs incoming quality testing on all production related materials and ingredients, collecting and organizing, retain samples when necessary.
- Determine disposition of product/material placed on QC Hold and close QC Holds when completed.
- Collect, Review, sign off, log, file and follow up on quality management system paperwork and communicates findings when necessary.
- Maintain both manual and electronic records to ensure only the most current forms are used and all completed paperwork is filed appropriately.
- Perform internal audits and communicate findings to Quality Manager/Director and operations team when necessary
- Perform Root Cause analysis for all quality related issues. Develops with operations team corrective actions/preventative actions and monitors for effectiveness.
- Coordinate with production the monitoring of processes and procedures to ensure effectiveness and continuous improvement.
- Assist with equipment calibrations and ensure they are up to date and accurate physically and in the calibration master list log, discontinuing use of any instrument out of calibration.
- Perform equipment verifications to ensure instruments maintain calibration in between calibration dates.
- Assists with creation of new SOPs and/or revision of existing documentation.
- Participates in all necessary audits.
- Follows all safety regulations.
- Performs other related duties as management requires
To perform the job successfully, an individual should demonstrate the following competencies:
• Analytical - Collects and researches data; Uses intuition and experience to complement data.
• Design - Generates creative solutions.
• Problem Solving - Identifies and resolves problems in a timely manner; Develops alternative solutions; Works well in group problem solving situations.
• Technical Skills - Pursues training and development opportunities; Strives to continuously build knowledge and skills.
• Customer Service - Responds promptly to customer needs; Responds to requests for service and assistance; Meets commitments.
• Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification.
• Written Communication - Writes clearly and informatively; Able to read and interpret written information.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views.
• Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time.
• Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment.
• Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles.
• Professionalism - Approaches others in a tactful manner Accepts responsibility for own actions; Follows through on commitments.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity.
• Safety and Security - Observes safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions.
• Initiative - Volunteers readily; Seeks increased responsibilities; Asks for and offers help when needed.
To perform this job successfully, an individual must have 4+ years related experience and strong knowledge of manufacturing processes, computer, and equipment validation, GMPs, and product/process validation. Be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
EDUCATION AND/OR EXPERIENCE:
Bachelor’s degree (B.S.) in related field or program certificate; and/or training; or equivalent combination of education and experience.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.
Proficiency with the use and understanding of Microsoft Operating systems and Office suite applications, ERP systems; NetSuite preferred.
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand for long hours and speak and hear. The employee is regularly required to walk; use hands to finger, handle, or feel and reach with hands and arms. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 10-25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; fumes or airborne particles; risk of electrical shock; risk of and vibration. The noise level in the work environment is usually moderate.
Please send resume to firstname.lastname@example.org