Document Specialist

Summary

The Document Control Specialist works under the general direction of Head of Quality.  The primary responsibilities are: creating and updating Filling and Packaging Instructions, validation documentation and managing change control documentation.

Essential Responsibilities

·         Help Develop, implement and maintain Filling and Packaging Instructions.

·         Maintain and manage Validation protocols, executed protocols and Validation Master Plan.

·         Maintain and manage Change Control program.

·         Assist QA Director with maintaining and management of Quality Systems Management documents.

·         Establish priorities to ensure timely job completion.

·         Assist in investigations related to Nonconformance or OOS, Customer Complaint etc.

·         Provide Department related data, trends etc. for Management Review.

·         Assist in updating or writing Department related SOPs and Work Instructions or other Department related documents.

·         Consistently demonstrates excellent interpersonal skills and professionalism to company management, all levels of staff and vendors and outside agencies.

·         Complete all other additional tasks assigned by supervisor.

·         Adhere to company policies and procedures and sets a positive example for others within the organization.

Qualifications

To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·         Discretion in handling confidential and sensitive matters.

·         Knowledge of drug cGMPs, SOPs and regulatory guidelines including FDA requirements.

Education, Experience and Licensure

·         Bachelor’s degree in science (chemistry, pharmacy, or biology) or equivalent work experience. 

·         2 years Quality Control related experience in a cGMP OTC manufacturing environment.

Technical Skills

·         Proficient use of Microsoft Office products including Word, Excel, Outlook and PowerPoint. 

·         Ability to quickly learn new software programs as needed.

Language Skills

·         Must be able to clearly and concisely communicate verbally and in writing in English.

·         Must be able present information in front of groups in a clear and concise manner.

·         Ability to speak and understand Spanish is a plus.

Mathematical Skills

·         Must be able to analyze and present quantitative data.

·         Able to accurately compute basic mathematical equations such as addition, subtraction, division, multiplication and percentages.

Reasoning Ability

Must be able to analyze and interpret data relating to various projects and resolve issues and problems that arise including:

·         Resolve issues of a general, routine and complex nature and exercise appropriate judgment to escalate issues to senior management.

·         Effectively prioritize routine and non-routine work assignments to ensure goals and timelines are met.

·         Apply knowledge of Quality Control best practices, cGMPs, regulations, and Company policies to problems and provide appropriate resolution.

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions.

·         Must have good visual/organoleptic alertness.

·         Work will be conducted in a standard office and manufacturing environment with associated distractions such as noise from telephones, keyboards, talking, paging systems, production equipment and warehouse activities. Temperatures are regulated by facilities management and are not within the direct control of the individual.

·         Most work is done while sitting down, using a computer keyboard and gazing at a computer monitor.

·         Position requires the incumbent to move from the work area to other areas of the company, including other offices, cubicles, warehouse and production areas, conference rooms and other offices in the same building or another building. The incumbent may be required to walk or drive his or her own vehicle to a second location a short distance away.

·         Must be able to sit for up to eight hours per day, lift and carry up to 20 lbs with or without assistance, reach above shoulder height, bend, stoop, and crawl to retrieve items from under a desk or floor level cabinet or drawer; push and pull, use a computer keyboard throughout the workday, stand while filing or performing other essential responsibilities.

·         Exposure to standard chemicals used in an office environment is expected and includes but is not limited to toner, glue and liquid paper or white out. Additionally, the incumbent will be exposed to chemicals used in the manufacturing process of cosmetics, and over the counter drugs.

·         Must have reliable transportation and valid driver’s license and be able to drive to appointments. Must maintain current, in-force vehicle insurance.

Salary : $25 - $28