AMAG is a biopharmaceutical company focused on bringing therapeutics to market that provide clear benefits and help improve people’s lives. Ouremployees work to develop and deliver important therapeutics, conduct clinical research in areas of unmet need and create education and supportprograms for the patients and families we serve. AMAG's products support the health of patients in the areas of maternal and women's health, anemiamanagement and cancer supportive care. Through CBR®, we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders, and have the potential to play a valuable role in the ongoing development of regenerative medicine.
AMAG's core values -- accountable, collaborative, transparent, sense of urgency, and results focused -- provide an important framework for who we are and how we operate. Our values are also foundational to the way we do business and are key to how we execute on our five year strategic plan 2015-2020: Growing, Building, Together. We take a patient-centric approach to continuing to grow our current products through meaningful investment in research toexpand the utility of these products and a strong commitment to patients and support programs.
In addition, we seek to build our product portfolio with additional therapeutics that could benefit from our business and clinical expertise. The successful execution of our strategy hinges on a talented and motivated team of employees who work together to make our plans a reality. Every day, the people atAMAG aim higher, devoting our passion and perseverance to finding new and better ways to support the health of patients and families.
The Senior QA Specialist is responsible for managing and facilitating the various components of the Quality Management System (QMS) including CAPA, Deviation, Quality Investigation, Change Control, and Product Complaint processes. This role will interface with key members of the quality organization and will collaborate with internal peers, senior management, regulatory officials, auditors, contractors and consultants as well as external vendors toensure AMAG functions in a complaint state. The Senior QA Specialist will also maintain oversight of manufacturers and service providers tasked with theperformance of critical operations within the AMAG commercial and clinical supply chain.
Duties & Responsibilities:
Primary responsibilities include, but are not limited to:
- Support, maintain, and further enhance Quality Assurance Operations as related to product quality and overall compliance within the context of a virtual sponsor/business partner environment. These responsibilities include but are not limited to:
- CMO vendor management – Assume ownership of specific vendor relationships across the product lifecycle. Vendor types include raw material suppliers, API supplier, drug substance manufacturers, drug product manufacturers, labeling and packaging sites, and Contract Test Organizations (CTOs)
- Internal and external audit support
- Third party and regulatory inspection participation and support
- Quality presence- ongoing vendor calls, site visits, and onsite production oversight
- Authoring, review and approval of documents including, but not limited to, internal procedures, vendor documents, executed and unexecuted batch records, QC testing data, and validation protocols
- Manage, facilitate, and participate in Product Complaint investigations, Annual Product Review, Material Review Boards, Change Control Review Board, and Specification Review Board, as needed
- Assist and collaborate with other departments, including but not limited to Technical Operations, Quality Control, Clinical Operations, Quality Assurance Systems, Regulatory Affairs, and Pharmacovigilance to ensure continued compliance, product quality, and patient safety.
- A minimum of a B.S. degree in science/engineering, or related field, with at least 5 years relevant QA or Quality-focused experience in a CMO, CRO or sponsor environment
- Quality-focused experience with sterile injectable products, combination products, or Class II medical devices
- Strong interpersonal communication skills, able to collaborate successfully and efficiently with internal groups and external Contract Manufacturingand Testing Organizations
- Excellent multitasking ability and ability to function in an environment with regularly changing priorities
- Proficiency with Microsoft applications such as Word, Excel, and PowerPoint
- Excellent understanding and ability to ensure compliance to cGMPs, Part 11, FDA, ICH, Health Canada, and EMA regulations as related topharmaceutical and medical device manufacturing
- Ability to travel internationally and domestically (travel up to 15%). Ability to travel at short notice and for fluid timeframes is also a plus.
- Prior experience with onsite manufacturing of aseptically-filled, terminally sterilized, and/or combination products is highly preferred
- Ability to review and interpret QC data including, but not limited to HPLC, GC, atomic absorption spectroscopy, as well as compendial wet chemistry assays
- Experience with Google Docs and Smartsheet a plus
- Capability to learn additional software applications and hardware capabilities also desirable
- Ability to identify improvement and foster change in a growing, fast paced environment