QA Document Control Support

Canton, MA

Posted: 01/12/2023 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
  • 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.
The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

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 :

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

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


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.

Meet Your Recruiter

Felice Santiago

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