A QA Specialist II (Quality Operations) ensures that manufacturing and related processes comply with regulatory and quality standards such as GMP and ISO. The role involves supporting production activities, reviewing documentation, overseeing compliance, and contributing to continuous improvement in a biopharmaceutical or life sciences environment.

This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submission/documentation for specific projects working as or working with the Regulatory CMC Lead and key stakeholders, primary contact for affiliates on Regulatory CMC activities in the assigned regions and managing of routine and non-routine Health Authority interactions as delegated. Depending on the stage of development and complexity of the program, this role can be a Regulatory CMC Lead for early stage development programs or working with the Regulatory CMC Lead for late stage development or commercial programs. The Regulatory CMC Lead is the primary global contact for Regulatory CMC activities, as delegated. This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, Regulatory CMC knowledge and interpersonal skills are required. 100% Remote or hybrid (Cambridge, MA or RTP)

Location: Portsmouth NH. Looking for a candidate with science degree and some manufacturing experience

This position for employment is in the Andover Quality Control Microbiology Laboratory working first shift supporting Laboratory operations Monday through Friday with occasional weekend and holiday coverage. The candidate should be flexible to support both assays performed in the Laboratory, as well as office-based work as needed to support the business. Non-Standard Work Schedule, Travel Or Environment Requirements Some rotational weekend and Holiday coverage is required to support the commercial manufacturing schedule. Adhere to safe work practices and procedures, including aseptic gowning procedures

Location: - Westborough, MA 01581 (On-site) The primary purpose of the Analyst I position is to Support Quality Control Microbiological testing of drug substances, raw materials and process intermediates in support of clinical development and commercial programs under cGMP and GLP guidelines, address excursions and conduct investigations.

Location (mandatory): Portsmouth NH USA 03801 Small Description: The QC Specialist II will join the Quality Control department and assist with technical transfer activities, contributing to the testing and analysis of in-process samples, final product testing, and stability studies. This role requires familiarity with GMP (Good Manufacturing Practices) systems, quality records, and testing methodologies. The individual will work collaboratively to complete complex tasks while ensuring adherence to industry regulations, contributing to method transfers, instrument qualifications, and validation activities.

Location (mandatory): Pleasanton, CA 94588 The Product Manager / Product Evaluator II supports food product development by managing product samples, documentation, testing, and evaluations across multiple categories. This role plays a key part in new product demonstrations, sensory evaluations, and finished product specifications while ensuring food safety, quality, and accurate reporting—enabling product development teams to focus on strategic initiatives.

Location:- Cambridge, MA 02141 (Onsite) Work Schedule: Generally, Monday to Friday 08 Am to 05 Pm EST (slight flexibility in hours) potential weekends (max 40 hrs)

Location (mandatory): Vacaville California With limited supervision, QC Associate I, is responsible for the performance of direct materials testing in accordance with cGMP regulations. These duties include execution of laboratory testing, trend analysis, documentation review, support of discrepancies (OOS, OOT, OOE) and other laboratory support activities. In conjunction with Quality Control leadership, the QC Associate II works to meet departmental and organizational goals.