Quality Engineer

Quality Engineer who, under minimal supervision, provides Quality oversight activities for the aseptic fill/finish manufacturing suite and Quality Assurance technical expertise to ensure aseptic manufacturing facility, processes, and support systems are compliant with company guidelines and CGMP regulations marketed products and/or their raw materials, APIs, excipients or components.

100% Onsite in Billerica, 5 days a week.

Must Haves: 2 years exp with fill finish, quality events, capa, change controls, on the floor batch records, aseptic exp.

Key Responsibilities/Essential Functions

• Provide technical expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events.
• Collaborate with cross-functional production support teams to identify root cause and determine appropriate corrective action/preventative actions for investigations.
• Resolve unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on evidence.
• Review and approve protocols, validation documents, investigations and procedures.
• Approve change controls and represent Quality in Change Control Board meetings as needed.
• Provide Quality on the floor presence in support of manufacturing operations.
• Represent QA in a range of internal team meetings, processes and initiatives.
• Alert management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.
• Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
• Actively demonstrates the values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
• * In the case of absence, reports to Manager above or a peer incumbent will function as a backup for this position.

Basic Qualifications

• BS/BA degree in a scientific discipline with 2 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.
• This position is site-based and requires a presence on-site five days per week.

Other Requirements

• Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities is preferred.
• Routinely scheduled work, and/or work required on evenings, weekends, and or holidays and, even in adverse weather conditions to support manufacturing operations. See Essential Personnel Policy.
• Handling of and, or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures and use personal and protective equipment provided.
• Ability to travel up to 10% domestically.
• Work Schedule is Monday - Friday 10-6pm