ERP Quality Systems Contractor

Job DescriptionJob DescriptionThis is a 1099 Contract opportunity.

POSITION SUMMARY:
Day-to-day responsibilities are primarily focused on the implementation of quality processes within a new Enterprise Resource Planning (ERP)system.  This role will also be involved in the reviewing and compiling of documentation for finished product releases, supporting internal manufacturing by performing quality assurance tasks, and managing the equipment and calibration programs. 

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:

• Participate in the design, building, and validation of Quality processes within the ERP system.
• Writing, editing, and proofreading work instructions and procedures to support ERP implementation
• Train end users on how to execute their functions within the ERP.
• Issue internal batch records for GMP production. Prepare and review lot number and expiration date calculations and ensure compliance of batch records with GXP requirements.
• Compile product release records into the eQMS system, issue product shipment authorizations.
• Maintain and issue logbooks.
• Schedule calibration activities, support equipment qualification processes, and interface with cross-functional teams to ensure compliance to equipment administration program.
• Collaborate with other departments to maintain compliance and ensure product quality and patient safety.

• Communicate effectively with all groups
• Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• Super-user ERP experience with an ERP system, preferable NetSuite.
• Minimum 5 years of experience the life science industry.
• The candidate will possess broad experience within the Quality function. 
• The candidate will be a problem-solver with the ability to exercise sound judgment under challenging circumstances.
• Excellent communication skills with the ability to effectively promote intra-and inter-organizational cooperation.
• Possessing strong character with self-confidence and integrity necessary to ensure that the best-interests of product recipients and customers are always of first and foremost importance.
• Strong background in a manufacturing and operations environment preferably supporting drug-device combination products, medical devices, and/or aseptically-produced pharmaceutical products.
• Experience working within vertically integrated and virtually-structured settings for small- to mid-sized organizations is .
• Technical, equipment, software knowledge necessary

ENVIRONMENTAL CONDITIONS:
Physical Activities:  On a continuous basis, be at a desk for a long period of time; intermittently answer the telephone and type on a computer. Some walking and lifting up to 20 lbs. may be required.  The noise level in the work environment is usually low to moderate. 

The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities of this job.
 

Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.

Powered by JazzHR

qKIWtA5WOr