Documentation Coordinator - Temp to Hire job

Job Description

Job Description

Job Title: Documentation Coordinator

DEPARTMENT: Sterilization

EXEMPT: No

REPORTS TO: Operations Manager

REVISION: 1

APPROVED BY:

DATE:

SUMMARY:

Coordinate the accurate and timely sample preparation, documentation and status for customer orders.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

      Primary contact for sterilization customers. Answer customer requests.

      Perform incoming and post processing inspection of customer product, prepare samples and documentation as required to meet customer specifications. Review samples and associated paperwork for accuracy, coordinate corrections with customers. Assign lot numbers, review and initiate Lot Control Records (LCR's), prepare and affix lot status cards.        Maintain and update computer data base and all other activities associated with ensuring customer orders are processed and documented correctly.

      Prepare samples and paperwork for shipment. Coordinate shipment to required laboratories; update status lists as required.

      Review accuracy of samples and associated paperwork for every lot processed through sterilization.

      Perform customer inventories as required.

      Maintain inventories of supplies and forms as required for sterilization operations and facilities. Reorder as necessary once approved. Monitor delivery status to ensure stock is maintained to prevent interruption of service.

      Assist in maintaining all quality records for the facility.

      Maintain compliance with company work instructions and all regulatory bodies such as ISO, FDA, USEPA, PADEP, cGMP/QSR and OSHA.

      Initiate and assist in the completion of quality system documents.

      Identify and report process defects to management and quality; ensure defective material is segregated and stored in proper warehouse location.

      Participate in customer and regulatory audits.

      Maintain the cleanliness of the documentation area, ensure the area is free of safety hazards and follow the safety rules.

      All other tasks as assigned by management.

QUALIFICATION REQUIREMENTS:

To perform this job successfully, an individual must 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:

Minimum 1 year of experience in administration and customer service and high school diploma or general education degree (GED) is required. Experience in a medical or pharmaceutical manufacturing industry is desired. Ability to complete responsibilities with minimal supervision is required. Basic computer skills are required.

LANGUAGE SKILLS:

Ability to read and interpret documents such as safety rules, operating instructions, and manuals.

MATHEMATICAL SKILLS:

The ability to add, subtract, multiply, and divide in all units of measure.

REASONING ABILITY:

Must possess the ability to apply common sense understanding to carry out written or oral instructions, and solve routine mechanical problems with limited supervision.

OTHER SKILLS and ABILITIES:

Good reading, writing, proofreading, organizational and editing skills.

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.

While performing the duties of this job, the employee is regularly required to stand and walk, use hands to manipulate objects or controls, reach with hands and arms, talk and hear. The employee may occasionally be required to climb, balance, stoop, kneel, crouch, or crawl. The employee is occasionally required to sit.

The employee must regularly lift and/or move less than 50 pounds with or without the use of mechanical means. Specific vision abilities required by this job include close, distance, color, peripheral, depth perception, and the ability to adjust focus. Specific auditory abilities required by this job include the ability to perceive sounds.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Office and warehouse/industrial setting with potential for exposure to fumes or airborne particles, working near moving mechanical parts, working in some precarious places, working off ladder, outdoor weather conditions, working in wet or humid conditions, working with hazardous chemicals, work with personal protective equipment requirements and with some risk of electrical shock. Moderate to loud noise levels exist.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 EOE