Job Title: Documentation Control Specialist
Date Posted: 07-23-2008
Job Location: Massachusetts-Boston North
Job Type: Full Time
Education Level: Bachelors Degree
Work Experience: 2+ to 5 Years
Job Shift: First Shift
Yearly Salary:30K-50K
Company Name: Lab Support
Contact Information: HR   Director (boston@labsupport.com)
Job Description:
Are you looking for a company with science in its DNA?

Lab Support, a division of On Assignment, is a recognized leader in the scientific staffing
industry. Since 1985, our sole focus has been to place scientific professionals at all career
levels in contract, contract-to-hire and direct hire positions. With a reputation for
one-to-one career counseling and a track record that includes the placement of over 200,000
scientists, Lab Support has built a reputation as one of the best in the business. 

Lab Support is supported by a nationwide network of branches serving all major markets,
international branches in Europe, relationships with leading scientific companies and over 20
years of experience putting People First! 
 
 
  Documentation Control Specialist


General Accountability
The Document Control Specialist reports to the Quality Manager and is responsible for the
design, implementation, maintenance  and improvement of document control processes including
document control software application upgrades, procedures, good documentation training of
staff, document control system, record retention, change control, training records and batch
issuance and review. In addition, the position is responsible for supporting the internal
GLP/GMP auditing program, and assisting in the compilation of regulatory submissions. Support
role includes clerical duties as required for maintaining quality systems within the QA
department, primarily QA filing activities for document receipt, issuance and handling. S/he
will ensure compliance with applicable regulatory requirements by directly working with
external manufacturing quality organizations and internal/external partners.

 

RESPONSIBILITIES: 

∑         Drive, execute and track records and documentation processes throughout the
documentation lifecycles including but not limited to:

o        Generation and control of document change requests

o        Document formatting and word processing from redlines

o        Routing, tracking and facilitating timely documentation review, approval and
periodic/annual review

o        Control, distribution and maintenance of internal procedural documentation and
records

o        Indexing, archival and retrieval

o        Maintenance of product specification files

o        Maintenance of electronic department directories

o        Develop and conduct Document Control related training

o        Creation of Master Batch Records and issuance of Batch Records. 

o        Coordinate and compile Batch Record History documents

o        Assure all material are released

o        Initiates the creation, review and revision of procedures, specifications and forms

o        Track and report on document review progress 

o        Track and trend all NCRís, CAPAís, and Change Controlís

o        Assure completeness of all documentation

∑         Track and maintain other internal records including training, Design History
Records, equipment records and laboratory notebooks 

∑         Assist with the implementation, management and administration of the quality system
electronic management systems 

∑         Review and proofread documents for consistency of document format and system
concerns 

∑         Verify and issue production documents and product labels to the manufacturing
department 

∑         Assign lot numbers, material part numbers, change control numbers, issue numbers,
equipment numbers and various other unique tracking identification

∑         Provide support for the Quality System during corporate audits 

∑         Perform audits of company areas and processes to confirm compliance with controlled
procedures 

∑         Prepares and processes status reports, assigns and monitors document numbers, and
reviews documents for accuracy and completeness.

∑         Maintains training files and job list for each employee and reports any deviations.

∑         Provides support on various other projects as necessary, ensuring the precision,
accuracy, and reliability of the GMP process.

∑         Maintains the GMP change control program by ensuring completeness of change control
documents for accuracy and compliance; establish reporting metrics and provide follow up on
implementation plan items for change control closure.

 

 REQUIREMENTS: 

∑         Experience with Quality System Documentation and good documentation practices 

∑         Knowledge of ISO, FDA and cGMP concepts and guidelines. 

∑         Ability to communicate effectively, verbally and in writing, and demonstrate good
interpersonal skills interdepartmentally and with external vendors and contractors 

∑         Work on complex assignments in collaboration with various department system owners.


∑         Analytical problem solving and organizational ability. 

∑         Demonstrated ability to work accurately, follow instructions/schedules/timelines and
handle multiple priorities. 

∑         Professional, well-organized, and eager to learn and be challenged. 

∑         Ability to utilize multiple word-processing and database applications including MS
Office applications Word, Excel, Access, Power Point as well as Adobe Acrobat, etc. 

∑         Works under minimal supervision 

∑         Candidate must be flexible and able to adapt to changes in priorities. 

∑         Prior experience in medical device or other GMP-regulated industry is preferred. 

 

 

 


Contact Name: Kristin O'Brien
Contact Email: boston@labsupport.com
Company: On Assignment
Address: 1 New England Executive Park
Burlington,MA 01803
Salary:  38,000.00 - 48,000.00 USD /year
Job Status:  Full Time, Temporary/Contract/Project, Employee
Category:  Biotechnology and Pharmaceutical
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