SUMMARY: The Coordinator Quality will process all Standard Operating Procedures for the MO site. This includes keeping the intranet site updated and maintain the SOP training database. As Coordinator Quality you will compile and process the Annual Product Reviews for drug products and required cosmetics. Maintaining and trending quality data for executive reporting, internal and external failure analysis.

Essential Functions

• Ensuring all SOPs are processed in a manner to ensure compliance to the GMPs. This includes maintaining change control records for SOPs, issuing out required review records, acquiring QA approval along with applicable department approval before making a SOP active on the intranet
• Maintaining a SOP training and GMP training database for this site
• Monitor and report to supervisors on outstanding training
• Conduct training as needed
• Maintaining the Annual Product Review data for the site. This includes compiling data from QC, PD, batch records, and other. The annual reviews are for all drug products and cosmetic products for some key customers, including Canada GVP. Coordinate investigation and resolution on all customer complaints assigned to MO operations. This includes timely reporting of any adverse events or high concerns to management
• Assist with Quality Metrics, General Quality reporting, Audit Support, and Master Data as backup
• Assists QA Director and VP of Quality with special projects
• Complete mock recalls for MO & TN, creating “what if scenarios”, and reporting twice per year
• Participate in audits
• All other duties as assigned

Supervisory Responsibility:

Education: High School Diploma or GED is required. Two years of college level course work is preferred or equivalent knowledge in math, science and computers achieved from work experience and/or on-the-job training.

Experience:

A minimum of 2 years’ experience in a cGMP regulated industry is preferred. Ability to work in Microsoft programs (Word, Access, and Excel) and an ERP system is required.

Competencies:

• Exhibit team player qualities of cooperation and coordination
• Professional interaction in all business contacts, all day, every day
• Possess a sense of energy and initiative. Be pro-active
• Present for work when scheduled is a mandatory function
• Compliance with all company safety rules, procedures and guidelines is essential
• Reporting of safety issues is mandatory

Travel: None

Physical Demands: Walking, talking, hearing, climbing, balancing, reaching, grasping, standing, and stooping. Occasionally lift boxes of products 5-60 lb. frequently lift samples 1-5 lb. Clarity of vision at 20 feet or more and 20 inches or less, ability to distinguish colors, and ability to adjust eye to bring objects in to sharper focus.

Knowledge: Requires the ability to read and understand instructions, write, add, subtract, multiply and divide.

License(s)/Certification(s) Required: None identified.

Machines, Tools, Equipment and Work Aids: Computer and related programs (MS Office environment, Word, Excel, Outlook, MS Access and MS Project nice to have, ERP), fax, copier, and other standard office equipment. Working knowledge of production equipment, conveyor, tape machines, shrink sleeve heaters.

Work Environment:

Worker exposed to normal office conditions. Worker occasionally exposed to warehouse or production environments. Worker will be exposed to ambient noise level in a manufacturing environment. Worker exposed to physical conditions such as proximity to moving mechanical parts. Worker occasionally exposed to atmospheric conditions such as fumes. This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands:

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 talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

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JOB TITLE:Coordinator Quality – Sample Room

DEPARTMENT: Quality Assurance

FLSA: Exempt, Salaried

JOB REQUIREMENTS

EDUCATION: High school diploma or equivalent.

EXPERIENCE: A Bachelor’s degree in a related filed is preferred. Proficient in Microsoft Office products including a minimum of 2 years computer software experience in a work environment.

SPECIAL KNOWLEDGE: Must have working knowledge of computer usage including Microsoft Word, Microsoft Excel, Microsoft Access and SAP, and other word processing, database, or spreadsheet programs

TECHNICAL SKILLS: Works well with computers (ability to create spreadsheets, databases, etc…), Technical writing skills. Ability to analyze data & track trends. Ability to analyze problems utilizing basic quality tools (pareto charts, root cause analysis, gap analysis, etc…)

NON TECHNICAL SKILLS: Requires excellent writing and organizational skills.

PHYSICAL REQUIREMENTS: CRITICAL TO JOB: Standing and walking – 30% of time on job; sitting – 70% of time on job; Stocking shelves lifting cases; communicate (talking and listening) – 75% of time on job; identifying colors – 20% of time on job, ability to see. Ability to bend, stoop, and kneel and the ability to visually track moving objects.

ESSENTIAL JOB FUNCTIONS

1. Prepare mock-up and order samples for Sales Bids, Line Reviews, and other product showcase. This includes applying labels, filling containers, and an attention to detail for quality workmanship.

1. Order supplies and sample components in SAP. Request and coordinate with other departments to ensure material construction matches established standards. Effectively communicate timeline expectations to various team leaders.

1. Inspects shipments into the sample room for quality workmanship for stock or sales presentation.

1. Prepare shipments for FedEx Express, FedEx Ground and UPS. Any hazardous shipments must be handled in a manner consistent with Hazardous Goods Shipping Standards. Ensure all mailing and shipping procedures are in compliance with DOT, IATA, UPS, Fed-EX, DHL and USPS regulations.

1. Maintain sample room in an organized manner with appropriate shelf stocks in order to support requests for general frequently requested samples. Enter and update inventory tracking in SAP system.

1. Projects for QA Director as assigned.