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- Harrisburg, PA
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WHY YOU MIGHT BE INTERESTED This position will lead all site quality in QA and QC. This company is a well know on the world stage and is growing everyday. You will have 4 direct reports and about 30 indirect. WHAT WILL YOU DO IN THIS ROLEWorking with the global requirements to keep the Quality Management System in line with the local team. Department budgeting, personnel, investment planning for long-term objectivesWill work on all ISO Certifications in regards to cGMP compliance and auditsSet


We are looking for a Senior Regulatory Affairs Manager who will play a primary and integral role in the regulatory activities and initiatives at the facility. Incumbent will guide US regulatory strategies across multiple programs at this emerging facility, lead pre and post-approval submission activities, and serve as regulatory lead to interdisciplinary cross-functional groups across entire product life cycles. Key Responsibilities:Coordinate ANDA submissions to FDA, interact with regulatory....


Director of Clinical Development Cardio This global Pharmaceutical company is the worldwide biologics research and development leader. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Director, Clinical Development in Gaithersburg MD or Cambridge UK, you’ll play a pivotal role in....


If you are an experienced Food Safety Manager in the prepared/packaged food industry and are looking for an opportunity to make an impact, this may be the place for you! Top 5 Requirements: 1. Bachelor’s degree in Food Science, Microbiology, Biology or related field is Required.2. Product experience should include food products.3. Technical knowledge of food safety, food science, and regulatory requirements is a must.4. Ability to demonstrate an understanding of process control methods and....

- Owensboro, KY

QUALITY ASSURANCE MANAGER We have a unique opportunity to join our team as a QA Manager of one of our food processing plants. Our company is a privately held, family friendly culture with over 50 years of experience serving our customers. We provide high quality, packaged food to the retail, food service and contract packaging markets. Our retail brand has been consistently growing for over 2 decades and we are searching for a leader in Quality to help us continue to propel our company forward


Top Tier Pharmaceutical company (with focus in RESPIRATORY, CNS, Diabetes, Cardio, GI and more) in Madison, NJ is looking for three Clinical Trials Manager Consultants for Clinical Trials Group This is a one year contract and can continue for up to 4 years (1099 or w-2)SummaryParticipate in all aspects of clinical development and study management under the direction of the Director, or designee, which includes providing scientific, and/or logistical support to planned and ongoing trials CTM –....


Director, Medical Information for this leading pharmaceutical company in New England S Headquarters in Waltham, MA Looking for Senior Engineer for drug product unit operations- leadership scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation. Experience with continuous manufacturing, scale-up and PAT implementation is strongly desired. The individual is expected to integrate QbD principles, guide experimental design with a focus on process....


Three Medical Directors needed The Medical Director is a board-certified physician who has a history of clinical practice, and has significant experience in the cardio therapeutic area, Endocrinology or Renal, Nephrology therapeutic areas. The Medical Director is knowledgeable of the actions of regulatory bodies, in particular FDA, and has experience in clinical trials. An ideal candidate should have significant experience in renal cardio disease management and would thrive on proactively....

- Any US State

Global Pharmaceutical company is hiring Clinical Project Manager for their Clinical Development studies Day to day management of studies This position is responsible for providing oversight of Phase 1 to Phase 4 clinical trial implementation; ensuring clinical studies are conducted in a timely manner with milestones being achieved within budget.Essential FunctionsThe Clinical Project Manager for this Pharmaceutical company- will:Utilize Project Management techniques and methodologies to plan,....


Global Pharmaceutical company is looking for a Clinical Partnership Liaison Must have pharmaceutical, Biotech or CRO experience at this senior level. located in NYC must work in the office three days/week The Partnership Liaison is a key leadership role within Clinical Operations Business Operations Management. The role is responsible for implementing and driving the success of the Clinical Development sourcing strategy. The role is accountable for Clinical Development alliances with clinical....


The Clinical Operation Lead is responsible for developing operational strategy for one or more clinical studies, and leading the cross-functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Clinical Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of studies keeping the....


The Director/Sr. Director of Clinical Development Operations is responsible for clinical operations planning, oversight and execution of multiple studies within one or more clinical development programs. Strategic development and coordination of operational approaches, guiding study level staff, and optimizing vendor performance. Sophisticated internal (cross functional team members) and external (KOLs, site staff) stakeholder communication and interface. Manage and/or mentor Clinical Trial....

- Branchburg, NJ

Job Description: QA/QC & Compliance Manager Responsibilities: Reporting to the VP of R&D, this position will oversee all operations to comply with the FDA, USDA, customer and company quality and food safety system standard. Specific responsibilities include:Design and implement food safety systemsMaintain and monitor all quality and food safety systems (GMP, Allergen Policy, Pest Control, Maintenance Plan etc.)Train all employees in food safety principlesAchieve SQF Level III....


Principal Scientist GLOBAL PHARMACEUTICAL COMPANY is hiring a Technical lead to design and execute analytical related aspects of pharmaceutical drug product development. Has broad and in-depth understanding of analytical techniques to support testing of a range of small molecules and macromolecules. Understanding of biomolecules and bioanalytical techniques including test methods to support clinical studies such as pharmacokinetics studies is desirable. Has method development/validation....


Join a Global Company as the strategic North American (NA) Team Leader supporting Analytical/ Synthesis (Methods Development); Product Metabolism, Product Safety (registration); and Regulatory Compliance (EPA). Participate on the Global Leadership Team while developing a challenged, problem-solving analytical team responsible for performing/ delivering scientific studies to ensure a sustainable product safety and registration success. The successful candidate will have a strong background in....

- New Haven, CT

Overview Our client is seeking a Product Quality Assurance Team Leader who will provide quality oversight of new device and combination clinical products from introduction throughout the product and design control lifecycle. As the product quality expert, the Product Quality Engineer will build the strategy to proactively minimize product quality and design control risks through early detection and mitigation during product development, technology transfer, commercial operations, and product....


The Senior Manager Clinical Operations is responsible for developing operational strategy for one or more clinical studies, and leading the cross functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Senior Manager Clinical Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of


We are looking for a Quality Assurance Document Control Associate to provide assistance with maintaining a GMP documentation system. Roles And ResponsibilitiesAssist in implementing information systems for managing document tracking, controlled document distribution (issuance) and records management.Oversee the issuance and maintenance of logbooks.Facilitate the final review of production batch records.Assist in administering the change control system (issuance, tracking, and....

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