QA Specialist II/Senior QA Specialist, Quality Systems (Contractor)
Apply NowCompany: Tessera Therapeutics
Location: Somerville, MA 02145
Description:
This is a contract position through the end of 2024.
Your experience includes...
You are interested in...
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
Company Summary:
Tessera Therapeutics is pioneering Gene Writing- a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.
More about Tessera Therapeutics:
Tessera is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, marital status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. Tessera provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with Tessera regarding a reasonable accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied, please contact the recruiter or A[redacted]
Recruitment & Staffing Agencies: Tessera Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Tessera Therapeutics or its employees is strictly prohibited unless contacted directly by Tessera Therapeutics' internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Tessera Therapeutics, and Tessera Therapeutics will not owe any referral or other fees with respect thereto.
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
Company Summary:
Tessera Therapeutics is pioneering Gene Writing- a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.
More about Tessera Therapeutics:
Tessera is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, marital status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. Tessera provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with Tessera regarding a reasonable accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied, please contact the recruiter or A[redacted]
Recruitment & Staffing Agencies: Tessera Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Tessera Therapeutics or its employees is strictly prohibited unless contacted directly by Tessera Therapeutics' internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Tessera Therapeutics, and Tessera Therapeutics will not owe any referral or other fees with respect thereto.