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Job DescriptionJob Description

Summary : The Quality Control Document Specialist is responsible for the creation, management and maintenance of the GMP related documents which includes but not limited to Standard Operating Procedures, test data sheets, controlled forms, deviation records, change requests, COAs, and other duties as needed and/or requested.

Duties and Responsibilities:

Reviews documentation to assure accuracy and completeness.

Performs reconciliation and closing of batch records in compliance with GDP

Assists on timely release of finished goods

Submits documents to customers (i.e. batch records, CoA, lab reports, etc.)

Assists in the initiation, investigation and closure of product and process deviations/non-conformances

Recommends corrective actions for quality issues

Assigns control number to Change Requests

Coordinates, schedules, and submits samples to 3rd party laboratories

Primary contact for 3rd party laboratories and follows up with status of submitted samples

Assist in investigations concerning operational problems and/or problems involving customer complaints

Assists in the preparation of complaint response for review and approval

Assists in the preparation of rework instructions for nonconforming products

Coordinates the creation, revision, and distribution of controlled documents to Management

Assists in training of plant personnel in SOPs and GMPs

Assists management in creating quality plans and standard operating procedures

Assists in preparation for customer audits and regulatory inspections

Authors and revise SOPs and other related quality documents

Maintains and files quality records, reports, logs, etc.

Manages document processes and systems to ensure control and availability of documentation

Transcribe data from COAs to raw material test reports

Assists in validation/verification efforts

Create and update raw material and packaging component specifications

Performs other related duties as assigned by management

Create finished product COAs.

Assists send retention samples to clients as needed.

Work Experience/Qualifications:

· Minimum of 2 years relevant work experience in document control management

· Working knowledge of cGMP’s and FDA regulations as it pertains to document control

· Good interpersonal skills

· Ability to work independently and in a team environment

· Ability to read, write, and speak English

· Ability to perform basic math

· Ability to follow instructions

· Good attendance and punctuality

· Flexibility to changing priorities, work schedule, and the needs of the business

· General proficiency in using Microsoft Word, Excel and Outlook

· Ability to work well under pressure

· Highly organized and detail oriented with ability to work effectively in a fast paced work environment

Education Requirements:

· Minimum High School Diploma or equivalent

Work Environment:

· 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 work near moving mechanical parts; fumes or airborne particles and risk of electrical shock.

· The noise level in the work environment is usually moderate.

· While in the plant, the employee is required to utilize the required personal protective equipment.

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.

· Physical demands require sitting and walking for extended periods of time, bending, reaching, carrying, and occasionally lifting and/or moving objects up to 25 pounds. Specific vision abilities required by this job include close vision, peripheral vision and ability to adjust focus. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl, and talk or hear.