Quality Assurance Administrative Assistant

The Quality Administration team is to carry out all administrative duties relating to the quality functions in accordance with Good Manufacturing Practice and relevant SOPs in line with user demand at any Almac site, ensuring all documentation completed by QA Administration is of a high standard and complies with Standard Operating Procedures and Good Manufacturing Practice Requirement

 

 

 

Maintain an accurate and secure document archiving system as follows:

 Scan Almac and customer approved documentation to Content Suite in high resolution and color where possible as soon as it becomes available in order to maintain the legibility of the document throughout the lifecycle.

 Archive key Quality documents such as Change Request documents, Quality Incidents and Technical Queries in a timely manner. Reference and append documentation as necessary and log onto the appropriate tracking systems.

 Facilitate shipment of documentation to off-site long term storge, customers and to other Almac Clinical Services sites 

 

Administration of activities associated with the SOP updates:

 Issue authorized copies

 Retrieve and account for superseded SOPs.  

Administration of activities associated with the PQS:

 Allocate electronic document references where applicable

 Logging of associated action items from Risk Assessments and Change Controls

 Issuance and reconciliation of logbooks 

Assist the Client Audit Managers with administration activities in support of customer audits

 

 

 

Report/escalate serious/potentially serious breaches of GMP compliance or matters of concern to QA Team Leader in an open and timely manner for appropriate resolution

Continuously consider opportunities for business improvement and be forthcoming with ideas/suggestions regarding process simplification and improve compliance

 

 

Handling multiple responsibilities and job tasks (multi-tasking) as needed.

 Demonstrating attention to detail.

 Flexibility with work requirements, work environment and fast-paced/changing job needs.

 Maintain professional working relationships and Almac core values while representing Almac on assignment.

 Acts as a representative of Almac when working on-site with client. 

 

BASIC QUALIFICATIONS & POSITION REQUIREMENTS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.

 

 

Bachelor's Degree

 

 3+ years administrative experience (with HS Diploma)

 2+ years administrative experience (with Associates Degree)

 1+ years administrative experience (with bachelor’s degree)

 

 1+ years working in quality assurance with a pharmaceutical company

 

 Electronic archiving systems

 Microsoft Office

 

Preferred Knowledge:

 Knowledge of Current Good Manufacturing Practices (cGMP)

 GMP document control/lifecycle

 Working with Quality Systems

 

Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills:

 Microsoft Word, Excel, and general computer skills

 Problem analysis and problem-solving skills

 Communication – verbal and written skills

 

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The dress attire is business casual as per the Employee Handbook.

 

PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Lifting:  Weight Requirement up to 35 Lbs

Moving/Walking:  Occasionally

Number of Hours/Day Sedentary: 2-3 hours/day

Number of Hours/Day Remain stationary: Occasionally

Number of Hours/Day Bending/Reaching/Twisting: 2-3 hours/day