SGS_JOB_2108
Contract - 12 Months
Location : Belvidere, NJ 07823. • The QC Analyst is responsible for analyzing and testing raw materials, intermediates, stability samples, and finished products under cGMP guidelines using validated or compendial methods. • The role involves performing laboratory analysis with minimal supervision, preparing reagents and standards, calibrating and operating instruments (HPLC, GC, ICP, etc.), and maintaining accurate documentation. • The analyst supports product release testing, investigates out-of-specification results, and ensures compliance with safety, quality, and regulatory standards. • Candidates should hold a degree in a relevant scientific discipline, have 0–3 years of laboratory experience, and demonstrate knowledge of quality control techniques, GMP, and safety practices. • Flexibility to work shifts, overtime, and weekends is required. • 0-3 years of lab experience • Experience in Microsoft Office (outlook, word, and excel) • The schedule may be structured with a required overtime component built in. • Candidates must be able to work shifts, weekends, overtime (including coverage) and holidays as required. • All candidates, both internal and external, applying for this position understand that overtime may be required and adjusted based on business needs and to ensure continued safe operations. Position content- • Key areas of accountability/responsibility • Performs analysis in the laboratory with minimal supervision. • Prepares standards, mobile phases, and reagents. • Calibrates and monitors laboratory equipment (HPLC, GC, ICP, etc.) • Analyzes raw materials, intermediates, stability samples and finished products for required tests by various analytical and instrumental methods. • Performs calculations, collects and prepares data for evaluation. • Keeps supervisor informed of work status • Investigation of OOS results under guidance of senior staff • Maintains good documentation practices.
Location (mandatory): Portsmouth NH The Quality Microbial Control Analyst V will be part of the Quality Microbial Control team, supporting the production of in-process and final product drug lots for customers. The role involves quality testing for customer stability studies, providing timely, high-quality results to meet Manufacturing demands. The Analyst will apply job skills, follow company policies, and contribute to projects and tasks of increasing scope. The role also provides technical support within the department and across the facility, potentially acting as a subject matter expert (SME) and supporting the supervisor in their absence.
Location- Westborough, MA 01581. The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Preferred: • Experience in a Biotech/Pharmaceutical company with a high growth, fast-paced environment. • Experience in qualification of analytical equipment, including those with computerized systems. • Experience in method validation/qualification/verification/transfer. Working Conditions: • This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs. • This is an on-site role working in a cGMP regulated manufacturing facility.
Location: Cambridge, MA 02139 Description: The primary role of the Media Prep Technician is to prepare pharmaceutical buffers, agar plates, and tissue culture media for Client’s lab operations in Cambridge, MA. Formulating buffers, plates and media for the PRD community allows our scientists to focus their time and skills on developing Breakthroughs That Change Patients’ Lives
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)
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.