- Repligen (Waltham, MA)
- …and quarterly close processes and ensures compliance with US GAAP and internal control requirements (SOX). This position supports general ledger accounting, ... including SEC filings support (10-Q, 10-K)Maintain documentation to support SOX internal control complianceParticipate in audit requests from internal… more
- Aequor (Thousand Oaks, CA)
- …accuracy. Job Summary This position is a unique opportunity to work within Quality Control at the Thousand Oaks site and to directly support both manufacturing and ... Quality Control operations. Under minimal supervision analyze environmental monitoring samples,...investigation of out-of-specification and/ or non-conforming test results. Supports internal and external inspections and audits as needed (lab… more
- Eisai, Inc (Exton, PA)
- …with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control , Validation, and other internal (PST) and external functions ... Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory, and CMC Program Management departments.The Associate Director of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(PV) oversight. This role fulfills the PV Oversight function in PV quality control processes, as well as providing SME-level input from the affiliate perspective ... Time' mindset to effectively perform quality assessments and deliver quality control on identified areas of focus within external pharmacovigilance (PV) partners… more
- Merck & Co. (Rahway, NJ)
- …leadership will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and ... all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including reviews/approvals of Change Control ... well as test methods and proceduresPrepares CCRs, according to change control processCoordinates, advances and monitors progress for all required documentations and… more
- Merck & Co. (Rahway, NJ)
- …and other regulatory requirements.Lead the operation of the site BAS and HVAC control systems. Manage the development and oversight of site operations through data ... while leading, developing, and motivating a cross functional team of internal employees and external service providers.Successfully navigate challenges and influence… more
- Novo Nordisk Inc. (Tyler, TX)
- …NNI-approved solutions Demonstrates professionalism and a customer-focused approach with internal and external stakeholders by actively listening, identifying and ... customers and patients' needs, and keeping commitments Develops and sustains internal relationships by collaborating across functions (eg Market access, Educators,… more
- Merck & Co. (Rahway, NJ)
- …technical integration, assembly automation, etc.), as well as members of internal cross-functional product development teams from concept through product launch. The ... and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence… more
- Merck & Co. (Millsboro, DE)
- …projects with a high level of technical difficulties and internal constraintsScheduling and planning for department requirementsCoordinate with department personnel ... to meet internal customer needs and requirementsCoordinate resources between areas of production utilizing the tier process to meet scheduling requirements.Provide… more
- Twist BioScience (South San Francisco, CA)
- …cGMP, GLP), FDA 21 CFR Part 11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, ... of manufacturing data, deviation management, and electronic signatures.Vendor & Internal Resource Management: Manage relationships with any external software… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …related projects. He/she will work with Planners, Manufacturing, Facilities, Quality Control , MSAT, and Engineering to support and improve the planning processes ... automation models using available data Ensure effective communication with both internal and external stakeholders Support internal /external Logistics teams to… more
- Twist BioScience (South San Francisco, CA)
- …a hands-on position that will be responsible for maintaining the company's internal financial statements and monthly financial close process. The Sr Manager ... records and controlsConsolidation of the monthly financial statements and internal reportingOwnership of the monthly close calendar, while proactively collaborating… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationships Reports to the VP, Enterprise Insights. Has responsibility of cultivating internal and external relationships that bring value and insights to the ... organization. Internal relationships include close interactions with marketing, sales, extended...Comfort operating in a fast-paced, environment, with a quality control focus and a documentation orientation Innate intellectual curiosity,… more
- Merck & Co. (Rahway, NJ)
- …substance processes. Your insights will be crucial for establishing an integrated control strategy suitable for commercialization and licensure for the products in ... that elevate our standards.Engage Across Functions: Actively interact with internal and external partners, representing your functional area on cross-functional… more
- Merck & Co. (Rahway, NJ)
- …as mass spectrometers and other spectroscopic techniques.Collaborate closely with internal company sites and Contract Manufacturing Organizations (CMOs) within the ... characterization.Provide documentation/technical input during inspections and audits (Regulatory and Internal ) and have a working knowledge of data integrity and… more
- Merck & Co. (Rahway, NJ)
- …environment that provides substantial technical responsibility and leadership of internal and external work.The Senior Scientist, Engineering position leverages ... expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a pivotal… more
- Merck & Co. (Rahway, NJ)
- …across all our company's divisions and functions to evaluate the adequacy of internal controls and deliver audit reports that add value to the area audited.Coaches ... of and techniques to assess risk and evaluate the effectiveness of internal controls in moderately complex business scenarios in accordance with timelines.Applies… more
- AUROBINDO (Durham, NC)
- …team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, ... customs and the FDA. The position is also required to work closely with Quality Control to make sure that the process flows smoothly from receiving the product until… more
- Merck & Co. (Rahway, NJ)
- …industry.Required Experience and Skills: Strong background in integrated analytical control strategy development and execution. Demonstrated ability to lead a ... knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related impurities in… more
