Quality Assurance Administrative Assistant

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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
Essential Functions
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 Retrieve and account for superseded SOPs.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. 
Promoting teamwork by:
  • Collaborating with co-workers.
  • Attending staff meetings as required.
  • Meeting individual company goals as established.
  • Establishing rapport and maintaining positive communication with others, demonstrating respect and support, cooperating and flexibility with change. 
  • Adhering to company and department policies.
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.
Required Education:  
  • High School Diploma or equivalent
Preferred Education:
Bachelor's Degree
Required Work Experience:
 3+ years administrative experience (with HS Diploma)
 2+ years administrative experience (with Associates Degree)
 1+ years administrative experience (with bachelor’s degree)
Preferred experience:
 1+ years working in quality assurance with a pharmaceutical company
Required Knowledge:
 Electronic archiving systems
 Microsoft Office
Preferred Knowledge:
 Knowledge of Current Good Manufacturing Practices (cGMP)
 GMP document control/lifecycle
 Working with Quality Systems
Skills (Inc. Typical Mental Demands):
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
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