Hobson Prior is working with a clinical-stage drug discovery and development discovering organisation who advance pioneering therapies to advance the standard of treatments for serious infectious diseases. Our client is looking for a QA Document Control Specialist to join them on a permanent basis, located in Oxfordshire or Cambridge, MA (US).

Job Responsibilities:

• Accountable to support the Quality Management System.
• Implements and manages the electronic quality management documentation management system including uploading and archiving documents and handling associated requests.
• Works closely with the Line Manager and the wider QA team in maintaining the quality objectives and embedding quality culture into the organisation.
• Delivers the 'Service Owner' role for the electronic Quality Management System to ensure the system is used by the wider organisation and any error reporting is handled in an effective manner.
• Ensures ongoing development and enhancement of the toolset to meet evolving business requirements.
• Provide support within the existing paper based QMS in terms of update, maintenance, drafting, QC of procedural documents.
• Checks / maintains the compliance and quality of the documents, in relation to Standard(s), Guidance and the organisations procedures and expectations.
• Responds to documentation enquiries, giving appropriate access to information.
• Supports in documenting internal and external audits in the QMS.
• Supports other functions in drafting, reviewing and approving documents / records using the QMS.
• Supports the implementation and management of non-conformance and CAPA systems within the QMS.

Key Skills:

• Demonstrated commitment to quality.
• Excellent communication skills, liaising with colleagues and system providers.
• Proven ability to change, prioritise accordingly and maintain strong organisational skills.
• Must have the ability to work independently and also a good team player, with proven ability to provide practical and pragmatic solutions with speed and efficiency.

Requirements:

• Minimum 5 years' experience, most likely gained through delivery of a similar role, with knowledge of administering a Document Control Management System in a Quality / Compliance orientated environment
• Mandatory experience in a biotech/pharma industry with electronic Quality Management Systems; preferred to have experience in both paper-based as well as electronic systems.
• A degree in life sciences or related field is preferable.
• Previous experience of writing standard operating procedures and migrating documents in an eQMS is essential (experience of working with MasterControl and/or Trackwise is preferable).
• Good Document Administration / IT (MS Office) skill-sets.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.