Qa Specialist

Company

CuriRx, Inc. was founded in 2012 with the goal of creating new standards of care in therapeutic areas with high unmet medical needs. We do this by partnering with our clients to provide innovative development solutions for pharmaceutics, biopharmaceutics, vaccines, generics, and biosimilars.

Job Description

CuriRx is expanding to a greater role as a cGMP provider and is seeking a creative, highly motivated individual who is ready for an exciting, entrepreneurial workplace and wants to contribute to a dynamic, success-driven team. The QA Specialist I will play an essential role in helping CuriRx transition from a CRO to a CRDMO, bringing their knowledge of quality systems to support the growing QA/QC team. Primary responsibilities will include document editing and management, assisting the Quality Assurance Lead with implementing and training staff on a Quality Management System to ensure the success of our clients bringing their products and services to market. The right candidate will be well-versed in quality assurance best practices and procedures and can work both independently and as part of a team to move the company forward. A certain degree of creativity and adaptability, along with the necessity of reaching consensus through a collaborative spirit, are required for this role, which will continue to evolve as the company grows.

Duties and Responsibilities:

· Maintains and updates the document management system and provides all related document services to the larger CuriRx team and to our clients as required.

· Assists in supporting the training program.

· Applies audit experience/training to assist during internal and vendor audits

· Creates or revises standard operating procedures related to quality assurance and quality operations.

· Involved in the development, implementation, and maintenance of quality management systems and activities.

· Responsible for assuring conformance to in-house specifications including Current Good Manufacturing Practices (cGMP).

· Performs a wide variety of inspections, checks, tests, and procedures in support of the manufacture of client products.

· Assists in creating guidelines for internal company standards conforming to Good Manufacturing Practices.

· Reviews quality records for conformance to cGMP and internal procedures.

· Reviews deviations and other CAPA documents for accuracy and compliance with SOPS and regulations.

· Assists with preparing installation and revising test validation procedures/protocols to ensure work is performed in accordance with appropriate regulatory agency validation requirements, internal company standards and current industry practices.

· Evaluates validation data, prepares reports, and discusses recommendations for change and/or improvement with management.

· Makes recommendations for corrective actions necessary to assure conformity with quality specifications.

· Performs the tasks required for the data review and release of materials or product components.

· Performs other duties as required.

Required Qualifications:

• Bachelor’s degree in chemistry, biochemistry, life sciences, or a related field with demonstrated experience and working knowledge of quality assurance principles.
• Master’s degree in chemistry, biochemistry, life sciences, a related field, or a professional certification such as ASQ or Six Sigma Green Belt or higher.
• Extensive hands-on experience with MS Excel, Word, PowerPoint, Visio, Adobe Acrobat, and other applications.
• Strong written and oral communication skills.
• General knowledge of cGMP regulations.

If you have the required experience and skills to succeed, and you are seeking a challenging opportunity in a growing company with a dynamic culture, submit your resume.

CuriRx is an equal opportunity employer and supports workplace diversity, a reduced carbon footprint, and fun.

Job Type: Full-time

Pay: $50,000.00 - $65,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 1 year

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person
• Office

Ability to Relocate:

• Wilmington, MA 01887: Relocate before starting work (Required)

Work Location: In person