What are the responsibilities and job description for the Document Control Associate position at ProStaff Solutions Inc?
ProStaff Workforce Solutions is seeking a Document Control Associate for one of the largest pharmaceutical companies in Billerica, MA. Our client is one of the leading pharmaceutical companies in the region and specializes in the production and sale of radiopharmaceuticals and formulation, analytical methods development and production of parenteral drugs. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.
Full-time Onsite
Long-Term Contract
Job Summary
Provides documentation support for all operations, issuance of laboratory notebooks, and maintains all document related systems to ensure regulatory compliance in accordance to 21 CFR Part 820.40 (Document Controls) and 21 CFR 211.100(a) (Written Procedures).
Area Of Responsibility
Qualifications
About ProStaff
We are a fast growing and successful agency that treats all its clients and candidates with a personal touch. ProStaff Workforce Solutions is a group of industry experts—many hailing from larger agencies—who know their business well and enjoy working in a more hands-on and flexible environment, with attention to detail. Our mission is to match quality people with quality jobs and quality companies to maximize productivity and profitability. We develop long-term relationships and provide a level of customer service and expertise that instill confidence and trust in our client companies and candidates.
Our Values
• Integrity
• Commitment
• Quality
• Diversity
Benefits for eligible employees
• Direct deposit
• Weekly pay
• Medical benefits
• 401(k) Plan
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
#IND2
Full-time Onsite
Long-Term Contract
Job Summary
Provides documentation support for all operations, issuance of laboratory notebooks, and maintains all document related systems to ensure regulatory compliance in accordance to 21 CFR Part 820.40 (Document Controls) and 21 CFR 211.100(a) (Written Procedures).
Area Of Responsibility
- Performs word processing and data entry tasks
- Scans and saves executes Batch Records into document management database
- Creates document file folders and maintain history files
- Assists in monitoring documentation due for periodic review
- Adheres to written policies and procedures related to performing assigned tasks
- Files and performs other organizational tasks
- Issues, tracks, and reconciles laboratory notebooks
- Coordinate the labeling and scheduling of boxes to be sent for storage offsite to Iron Mountain
- Responsible for reviewing and identifying all of the Quality documentation located in stored boxes, and to transfer all of the content of the boxes to the site inventory spreadsheet
- Maintain GMP document retrieval and accessibility
- Other duties as assigned
Qualifications
- High School Diploma or GED required; Degree preferred
- 1-2 years of related experience (pharmaceutical/drug, FDA regulated and/or medical device industry) preferred
- Excellent verbal, written and interpersonal communication skills
- Excellent Microsoft Office skills, including Word, Excel, and PowerPoint
- Working knowledge of Adobe Acrobat
- Must be detail oriented with the ability to multitask in a fast-paced environment
- Team player with ability to collaborate with others
- Exhibits flexibility and professionalism when dealing with changing priorities and assignments
- Customer driven with sense of urgency/priority in responding to customers' needs (internal and external)
- Comprehension and awareness of the importance of achieving regulatory compliance
- Familiarity with an electronic data management system (EDMS)
- Working knowledge of documentation functions within a cGMP or ISO regulated environment
- Ability to lift/move up to 10 lbs.
About ProStaff
We are a fast growing and successful agency that treats all its clients and candidates with a personal touch. ProStaff Workforce Solutions is a group of industry experts—many hailing from larger agencies—who know their business well and enjoy working in a more hands-on and flexible environment, with attention to detail. Our mission is to match quality people with quality jobs and quality companies to maximize productivity and profitability. We develop long-term relationships and provide a level of customer service and expertise that instill confidence and trust in our client companies and candidates.
Our Values
• Integrity
• Commitment
• Quality
• Diversity
Benefits for eligible employees
• Direct deposit
• Weekly pay
• Medical benefits
• 401(k) Plan
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
#IND2
