- This individual will be responsible for supporting the Commercial Quality Assurance team with day to day operations, including lot review activities for commercial drug substance, drug product and finished goods manufactured by CMOs.
- This individual will support project activities, product complaints, and other quality systems as they relate to commercial manufacturing.
- This person will be critical in providing quality oversight and coordination of QA activities with CMOs.
- This individual will be responsible for contributing to projects of moderate scope within QA, cross-functionally and with external business partners, including launch activities and transition of new products from the QA technical team to QA Operations
- This person will be responsible for managing own workload from multiple project managers to meet deadlines.
location: Cambridge, Massachusetts
job type: Contract
salary: $30.00 - 36.18 per hour
work hours: 9 to 5
- Performs documentation review, including but not limited to deviations, and executed batch records, thoroughly, with a high attention to detail, using working knowledge of cGMPs and internal procedures and controls.
- Maintains sufficient expertise in one or more QA disciplines to independently perform analysis and draw appropriate conclusions. Communicates with manager and other stakeholders (internal and external) to ensure communication of outcomes.
- Positively influences peers in achieving operational and project initiatives and objectives.
- Able to identify and resolve basic technical issues using problem-solving skills, in consultation with management and other cross functional departments.
- Provide support for regulatory inspections and GMP audits
- Responsible for engaging with internal and external organizations to ensure batch release timelines are met and issues are resolved.
- Actively participates in the planning and prioritization of multiple projects and/or the resolution of quality and compliance issues.
- Performs all required trainings on time. Actively participates in group trainings and coaching efforts.
- Compiles quality metrics demonstrating CMO site performance and presents at routine business meetings when requested.
- Able to identify complex problems and consistently propose solutions. Reviews goals and plan regularly and realign priorities consistent with organizational shifts. Continually seeks creative process improvements.
- Actively integrates big picture understanding into all interactions. Drives team cooperation and credibility focusing on positive results. Encourages communication, cooperation and win/win solutions.
- Performs additional duties, as assigned.
- BS in a science related field and 2+ years experience with 2 in QA or related compliance experience or
- Solid understanding of cGMPs as well as applicable regulations and guidances. Demonstrates expertise of department processes, tools and methods.
- Ability to handle multiple tasks concurrently and in a timely fashion.
- Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
- Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
- Must be able to read, write and converse in English.
- Must display eagerness to learn and continuously improve.
- Positive work attitude that supports teamwork and continuous improvement.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
- Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
- PHYSICAL DEMANDS
- Wrist and hand motion (e.g. typing, writing)
- Must be able to work in controlled or clean room environments requiring special gowning
- TRAVEL REQUIREMENTS:
- Willingness to travel to various meetings or client sites, including overnight trips
- Requires approximately 0-10% travel
skills: Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.