Kaztronix
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QA Document Control Support
Canton, MA US
Posted: 01/12/2023
2023-01-12
2023-04-29
Industry: Scientific
Job Number: 23-00025
Job Description
I. JOB SUMMARY
The main role of the QADC Support is to update internal records in alignment with process harmonization standards from global initiatives. The role may also support all daily activities of documentation management such as documentation record management, archival and retrieval of GMP documents, etc.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Document Control Support
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS Minimum Requirements
Preferred Requirements
The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical/Mental Demands and Work Environment Characteristics :
Mental Demands: [THE 5 CHECKED ITEMS BELOW MUST BE CHECKED FOR ALL POSITIONS; ADDITIONAL ITEMS WILL APPLY FOR HIGHER LEVEL ROLES IN THE ORGANIZATION]
Ability to organize/coordinate Comprehend and follow instructions
Direct, control and plan Independently make quick decisions to solve complex issues
Problem Solve Analyze/Interpret data and information
Perform with frequent interruptions Make decisions using sound judgment
Supervise/Manage others
Physical Demands:
Good eye/hand coordination Visual Acuity
Use keyboard/computer/phone Detect/Distinguish smell
Detect/Distinguish hearing Maintain stationary position
Position self to move Move/Traverse
Ascend/Descend (climb) Reaching
Calibrate precise Ability to safely operate hand tools
measurements
Move/Transport 25 lbs. Repetitive movement activities
Environmental Characteristics:
Regular and predictable attendance [MUST BE CHECKED OFF FOR ALL POSITIONS ]
Work around extreme temperatures cold or hot
Work around noise above conversation level
Work in restricted access to laboratory area
Exposure to dust/gas/fumes/steam/chemicals
Work with Select Agents as defined by the CDC
Work irregular hours that often include nights and weekends
Work in multiple locations
Travel:
Not Applicable
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
Document Control Support
- Generate, revise, and review SOPs and Work Instructions to align with global initiatives.
- Collaborate with team members and site customers to ensure timely deliverables for documentation objectives
- Must be capable to work independently and strategically to ensure day-to-day activities are carried out in support of the business goals
- Frequently interacts with direct manager, peers, internal customers, and other cross functional peers
- Support completion of department operational tasks related to record and document issuance, processing, and archival.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS Minimum Requirements
- Bachelor's Degree in Scientific or related fields
- A minimum of two (2) years of cGMP in QA documentation in Pharmaceutical industry
- Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
- The ability to coordinate multiple priorities in a fast-paced environment
- Excellent organizational, analytical, and problem-solving skills
- Excellent communication skills with the ability to interact with all levels throughout the organization
- Must be a team player and work collaboratively in a complex matrix environment
Preferred Requirements
- Microsoft Office Specialist certification.
- Document Management Certified Professional (or equivalent certification).
- Experience in maintaining CGMP compliance preferred.
- PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical/Mental Demands and Work Environment Characteristics :
Mental Demands: [THE 5 CHECKED ITEMS BELOW MUST BE CHECKED FOR ALL POSITIONS; ADDITIONAL ITEMS WILL APPLY FOR HIGHER LEVEL ROLES IN THE ORGANIZATION]
Ability to organize/coordinate Comprehend and follow instructions
Direct, control and plan Independently make quick decisions to solve complex issues
Problem Solve Analyze/Interpret data and information
Perform with frequent interruptions Make decisions using sound judgment
Supervise/Manage others
Physical Demands:
Good eye/hand coordination Visual Acuity
Use keyboard/computer/phone Detect/Distinguish smell
Detect/Distinguish hearing Maintain stationary position
Position self to move Move/Traverse
Ascend/Descend (climb) Reaching
Calibrate precise Ability to safely operate hand tools
measurements
Move/Transport 25 lbs. Repetitive movement activities
Environmental Characteristics:
Regular and predictable attendance [MUST BE CHECKED OFF FOR ALL POSITIONS ]
Work around extreme temperatures cold or hot
Work around noise above conversation level
Work in restricted access to laboratory area
Exposure to dust/gas/fumes/steam/chemicals
Work with Select Agents as defined by the CDC
Work irregular hours that often include nights and weekends
Work in multiple locations
Travel:
Not Applicable
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.