Specialist II/Senior Specialist, Quality Systems (Contractor)

This is a contract position through the end of 2024.

Your experience includes… 

• Bachelors degree in biology or related field with 5-7 years of industry experience; or Masters degree in related field with 3-5 years of experience.
• Previous experience in life sciences and eQMS management.
• Strong knowledge of cGMP regulations and eQMS systems, such as Trackwise or Veeva
• Ability to build strong working relationships with cross-functional departments.
• Comfortability working with minimal direction and able to adjust to a dynamic work environment.

You are interested in…  

• Coordinating document control processes within the eQMS, including document number issuing, reviewing document formatting, periodic reviews of documents, training authors and approvers to use the system, etc.
• Coordinating with cross functional teams for documents issuance, retrieval and storage of controlled documents.
• Maintaining filing and storage systems for document control.
• Collaborating with functional area leaders to identify training needs for all departments and maintain training curriculum.
• Coordinating employee training; including employee onboarding to the QMS, training plans, training content, and tracking training compliance.
• Providing support to eQMS users including administrative controls and system use support.
• Maintaining monthly metrics and reporting tools for all aspects of quality systems, i.e. presentation of metric performance to management representatives.
• The possibility of delivering group and individual instruction/training including new hire orientation.
• Maintaining and improving quality system procedures and programs including training programs and document control.
• Developing and implementing training and training tools for the Quality System to be used by all employees.
• Supporting internal audits and inspections, as needed, including backroom support.
• QC checking regulatory submissions as required.

About you: 

You are a driven, enthusiastic and self-motivated individual who is comfortable multitasking and working independently on various aspects of the quality system. You are excited about joining the QA team and managing day-to-day activities in support of the Tessera electronic Quality Management System (eQMS).

Tessera employees are creative and collaborative problem solvers. They have a strong sense of integrity and unwavering commitment to scientific excellence. 

Meet your Manager:

All inquiries regarding the posted position should be directed to the Talent Partner (see below). Interested individuals must apply directly to be considered for the opening. 

PK Karmacharya, Director, Quality Systems

Meet your Talent Partner:

Annie Edminster, Employee Experience and Talent Lead