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GENERAL DESCRIPTION
The Document Control Specialist is responsible for providing the support to the Quality and Regulatory group of Best Formulations. This position requires developing, coordinating, and maintaining the companys Controlled Document System in a fast paced, team oriented nutritional and drug manufacturing facility.
ESSENTIAL JOB DUTIES / RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential job functions. Essential job functions and duties include, but are not limited, to:
- Technical assistance on manufacturing & quality system documents.
- Provide word processing support, create & revise word processing documents
- Distribute current revisions of documents.
- Maintain and administer the system for assigning part numbers, filling control documents, marking changes to and initiating change orders, routing changes for sign off, and implementing change orders
- Print, review, files, archive and releases Manufacturing Batch Records, Standard Operating Procedures (SOPs), Analytical Procedures( APs), Material Specifications, and Process Specifications, and other Controlled Documents.
- Generates bulk labels for products manufacture within the company
- Maintain security and integrity of controlled documentation
- Maintain the master hard-copy documentation files, as applicable
- Ensure that all documentation is in compliance with Quality System Regulation and maintain current knowledge of GMP regulations
- Assist in representing Quality group during Internal & external audits
- Scan raw material & executed production batch records, COA's, MSDS, Specs and other documents and upload in electronic data base
- Follow established department SOP's, cGMP regulations, and batch record instructions.
- Complies with all Company policies and procedures, including safety rules and regulations.
- Maintains a safe work environment and operates in a safe manner.
- Perform other job duties related to the job, as assigned by management.
QUALIFICATIONS
The requirements listed below are representative of the knowledge, skills, education, and/or abilities required for the job:
- Proficient skills in reading, writing, and speaking in English
- Good written and oral communications skills & techniques.
- Basic math skills;
- Effective planning & organizing skills; ability to handle multiple task/duties.
- Proficient PC skills (Microsoft Word, Excel, PowerPoint).
- Effective problem-solving skills.
- Knowledge of general office skills and administrative procedures, including, but not limited to: typing (min. 45-50 wpm), filing, copying, faxing, editing, and development of memos, letters, reports, and correspondence.
- Ability to work independently and in a team environment
- Ability to maintain a positive, professional, cooperative demeanor, conduct, and working relationship with peers, management, employees, and other individuals that interact with this position.
- Ability to comply with Company policies, procedures, work rules, and protocols.
- Ability to adapt effectively to workplace changes and new job duties/responsibilities.
- Ability to represent the Company in a positive and professional manner at all times.
SELECTION GUIDELINES
The appropriate knowledge, skills and abilities required for this position are achievable through the following combination of education, work experience and training:
- High School Diploma or equivalent GED Certificate; and
- Minimum of 2 years of work experience in a fast-paced work environment; or
- Any combination of experience, education, and training that provides the level of knowledge, skills, and experience needed to successful perform the job.
PHYSICAL DEMANDS & WORKING CONDITIONS
The essential functions of this job require the employee to perform the following physical activities during the course of work:
- Communicates orally with management, employees, co-workers, vendors, suppliers, governmental compliance agencies, and the general public by telephone or in person, in one-on-one or group settings.
- Regularly uses a telephone, computer (e-mail) and fax for communication.
- Required to stand, walk, and sit for extended periods of time during the course of work shift.
- Routinely required to stoop, bend, kneel, lift, reach, pull, push, and tilt object in the performance of job function.
- Requires the essential use of hands, speech, eyesight, and hearing.
- Requires agility to operate multiple telephone lines with the use of hands and head-set.
- Capable of lifting 20 - 30 lbs. May have to manipulate heavier containers.
- Requires incumbent to sit and operate computer for extended periods of time during course of work day, and the ability to proficiently use the computer key-board for typing.
- Noise level for this work environment is typically low to moderate. Some work areas require hearing protection for an 8-hour work day.
- Periods of odoriferous environment.
- Work may involve moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, unpleasant odors, and/or loud noises. Personal Protective Equipment provided as necessary.
- Work environment may involve exposure to chemicals, solutions, detergents, or solvents that require following extensive safety precautions and may include the use of personal protective equipment.
- Work environment may involve exposure to allergens such as Soy, Wheat, Fish, Shell Fish, Milk, Egg, Tree nuts, and Sesame.
Note: The Company reserves the right to modify, update, change and/or make corrections to this job description, at the sole discretion of senior management, at any time during the employee's employment term, at the sole discretion of management.
Best Formulations is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Best Formulations will work with applicants to meet accommodation needs that are made known to Best Formulations in advance.
