Quality Assurance Administrative Assistant - Souderton, United States - Almac Group

Almac Group
Almac Group
Verified Company
Souderton, United States

1 week ago

Mark Lane

Posted by:

Mark Lane

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Description

The
QA Administrative Assistant is primarily responsible for carrying out document control and project specific duties related to the general implementation and maintenance of Almac quality systems held in accordance with Almac Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and customer specifications.


ESSENTIAL FUNCTIONS:
Administrative tasks to support the operation of the QA department including:

  • Process requests for additional pages to batch records for production.
  • Coordinate the intersite transfer of Almac documents and shipment of Qualityrelated documents to customer and regulatory representatives.
  • Support customer audits by obtaining GMP documents and information.
  • Provide administrative support to QA and QC staff including the following: Photocopying, Binding, Filing, Scanning/faxing.
  • Processing CAPA addendum/effectiveness forms.
  • Process Medication number list import and archive.
  • Assist Archivist as needed.
  • Administrative tasks to GMP documentation electronic systems:
  • Maintain and update electronic document systems. PA and other Almac sites if needed.
  • Create and maintain spreadsheets and databases of document reference numbers. Issue such numbers upon request.
  • Create, reconcile and update excel spreadsheet for cGMP logbooks for use by Quality and Operations personnel.
  • Issue Change Request Document (CRD) and Receiving (CRR) copies to appropriate documentation including SOPs, MBRs, etc and close document in MARS.
  • Ensure proper electronic and hard copy archiving of GMP documents as listed previously and including but not limited to environmental monitoring records, analytical test results, and validation documents.
  • Maintain control of Technical Agreements and Project Management Documents by: Issuing of controlled copies, circulating copies (signatory list), Updating MARS
  • Maintain control of SOPs and Policies by: PA and other Almac sites if needed.
  • Copying SOPs/Policies and issuing authorized SOP/Policy copies
  • Retrieving, reconciling, and destroying superseded/obsolete SOPs/Policies
  • Issuance authorized SOP/Policy copies to key trainers for training purposes

ADDITIONAL FUNCTIONS:

  • Computer literacy including spreadsheets and databases.
  • Assist Quality personnel as needed.

BEHAVIORAL REQUIREMENTS:

  • Handling multiple responsibilities and job tasks (multitasking) as needed.
  • Demonstrating attention to detail.
  • Flexibility with work requirements, work environment and fastpaced/changing job needs.

Promoting teamwork by:

  • Collaborating with coworkers.
  • 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.
  • Supervisory responsibilities of direct reports:
  • This position does not supervise or have direct reports.
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.

Preferred Education:

  • Associate's Degree or higher

Required Work Experience:

  • 5 years experience with a High School Diploma.
  • 2 years experience with an Associate's Degree or higher.

Preferred experience:

  • Work in a GMP environment.

Required Knowledge:

  • Electronic archiving systems
  • Microsoft Office

Preferred Knowledge:

  • GMPs and Quality Systems

Skills:


  • Effective oral and written communications skills.
  • Organizational skills.
  • Strong customer service skills.
  • Technical writing skills preferred.
  • Ability to form good working relationships with team members and superiors.
  • Meticulous, thorough, and consistent.
  • Ability to work on own initiative.
  • Ability to work to consistent high standards under pressure.
  • Strong interpersonal skills preferred.
  • Willingness to undertake additional responsibilities as required.

Additional Qualifications:

  • Customer service/client relations
  • Communication proficiency
  • Attention to detail
WORK ENVIRONMENT & DRESS ATTIRE


The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

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


What can Almac Group offer you?
-
Medical, Vision & Dental** benefits from the 1st of the month following start date
- **20 days PTO
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