Document Control

Location
Waltham, Massachusetts
Posted
Apr 24, 2018
Required Education
Bachelors Degree
Position Type
Full time

Inspiring advances in bioprocessing, Repligen is a leader in bioprocess filtration, pre-packed chromatography and Protein A ligands development. Propelled by a culture of innovation and collaboration, and with a focus on cost and process efficiencies, our people and our technologies help meet critical bioproduction demands worldwide.  Named one of the fastest growing biotech companies in the USA, Repligen is headquartered in Waltham, Massachusetts with major manufacturing sites in Massachusetts, California, Sweden, and Germany.  

Our Products

Repligen offers the broadest range of hollow fiber and flat sheet filtration technologies for cell culture and purification, featuring XCell® ATF Systems, Spectrum® KrosFlo TFF Filters and Systems and TangenX® Flat Sheet TFF Cassettes.  As the expert in pre-packed chromatography technology, Repligen offers OPUS® Pre-packed Columns with unparalleled flexibility and scalability from bench- to production-scale. Since 1985, Protein A affinity ligands manufactured by Repligen have been routinely used to purify most of the world’s monoclonal antibodies. 

The successful candidate will be responsible for assisting the document control department revise/create, file, organize, and review production documents. The candidate will work closely with the manufacturing team and document control department to ensure the changes are accurate and are made effective in a timely manner.   

Responsibilities: 

Works with subject matter experts, area managers and QA-Compliance personnel to properly convert documentation into the final written form and ensure the appropriate document approvals are obtained prior to documentation becoming effective.

Prepares and publishes approved documentation in a timely manner to meet established deadlines (paper and electronic)

Maintains related database systems, logs and complete forms/records as required

Adheres to written policies and procedures related to performing assigned tasks

Assists in the implementation of QA policies and procedures; adheres to policies and procedures when performing daily tasks

Regularly meets with the team to resolve issues, maintains time lines and plans in order to meet the company’s needs in the area of document control

Files and performs other organizational tasks

Organize and update training files as necessary to maintain compliance

Copy, scan, and file records appropriately

  • Maintain routine document control activities of document revision, batch record generation and label generation in support of the OPUS, Eliza and ATF production schedule
  • Detail-oriented with the ability to multitask in a fast paced environment
  • Team player with ability to collaborate with others
  • Customer driven with sense of urgency/priority in responding to customers' needs (internal and external).
  • Ability to shift priorities to support business needs
  • Must be a self-starter with the ability to work independently
  • Ability to exercise good judgment and be able to make decisions within prescribed guidelines
  • Other duties as assigned

Qualifications

  • Strong knowledge of Microsoft Office, including Word and Excel. MS Access a plus.
  • Excellent organizational and communications skills                               
  • Must be resourceful and self-motivated
  • Team player with ability to collaborate with others
  • Strong verbal, written and interpersonal communication skills
  • Working knowledge of documentation functions within a cGMP or ISO regulated environment is preferred