Quality Engineer Jobs

Boston, Massachusetts, United States

Summary:

42 North/Sequoia is looking for a Quality Engineer for support and oversight of Internal QA Operations for manufacturing mRNA-based drug products.

The individual in this role will be part of a cohesive team responsible for rapidly releasing cGMP mRNA-based drug products. S/he will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in clinical and/or commercial products. This individual will work closely with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Digital and Manufacturing Science and Technology counterparts.

Responsibilities:

• Oversees execution of CAPAs, deviations and change controls in support of PCV manufacturing.
• Develop batch records, SOPs and training materials as needed.
• Demonstrate a general knowledge of standard manufacturing compliance, quality disposition, quality system review.
• Monitor process operations to ensure compliance with specifications.
• Participate in quality oversight of manufacturing through real-time observations of activities.
• Assist in the investigation of procedural deviations.
• Author and review SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.
• Oversee and review executed electronic and paper batch record documentation.
• Closely partner with peers for rapid review of batch-related documentation.
• Reviews minor manufacturing deviations.
• Utilize knowledge to improve operational efficiency.
• Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.

Skills & Education

• Participates in determining objectives of assignment and plans, schedules and arranges own activities in accomplishing milestone achievements.
• Ability to collaborate fluidly with peers, supervisors and cross-functional support groups required
• At least 3 years of QA or Manufacturing experience in a GMP manufacturing environment with a Bachelor’s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry or related field.
• Must be able to work under general direction to plan, coordinate, and ensure completion of engineering team deliverables.
• Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
• Effective verbal and written communication skills.
• Excellent interpersonal, teamwork, and leadership skills required.
• Exceptional written, oral communication, and organizational skills required

42 North Solutions/ Sequoia offers a comprehensive suite of benefits including, medical, dental, vision coverage, 401K, and company paid life-insurance. Sequoia is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.