Equipment Validation Engineer - Fairfield, NJ- KatalystHLS.com

The Validation Engineer supports the successful implementation of laboratory/process equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope.

https://www.indeed.com/viewjob?t=equipment+validation+engineer&jk=5ad96d97e133dc91&_ga=2.16682678.1824577181.1561870312-1429968906.1557248850

Quality Control Associate / Client: Allergan - Irvine, CA

The QC Associate is responsible for performing hands-on quality related tasks in order to fulfill QA/QC support for implementing and maintaining QMS compliance as directed by management. This position is responsible for supporting and maintaining quality systems and functions within the company. This position may interact with management, partners, vendors, contract manufacturers and suppliers.

https://www.indeed.com/viewjob?t=quality+control+associate+client+allergan&jk=8ea1be610aab9c7b&_ga=2.164025020.2018469937.1561384222-1429968906.1557248850

Clinical SAS Programmer - Watertown, MA

performing data manipulation, analysis, and reporting of clinical trial data, both safety, and efficacy (ISS/Client), utilizing SAS programming; generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs).

https://www.indeed.com/viewjob?t=clinical+sas+programmer&jk=9ee3a58355a259c1&_ga=2.93126430.2018469937.1561384222-1429968906.1557248850

Clinical Data Manager - Bridgewater, NJ

Participates in the development, review and implementation of departmental SOPs, templates and processes Supports budget and resource planning across assigned projects Contributes to technical infrastructure of data management Participates in CRO/vendor selection process for outsourced activities

https://www.indeed.com/viewjob?t=clinical+data+manager&jk=f135e22f141d8e5f&_ga=2.88620696.2018469937.1561384222-1429968906.1557248850

R&D Asistant Scientist Contractor - Houston, TX - KatalystHLS.com

Support the legacy specification upgrade (LSU) project as part of GFGC Measurement Sciences. Learn and understand ingredient/supplier/third party/formula standards. Research industry reference test methods and determine appropriateness for a given parameter on a specification.

https://www.indeed.com/viewjob?t=rd+asistant+scientist+contractor&jk=ff65f6ba276b06be&_ga=2.83013009.640713282.1560794882-1429968906.1557248850

QA COMPLAINT SPECIALIST - Austin, TX - KatalystHLS.com

They will be responsible for answering inbound calls and collecting all pertinent information for the complaints. They essentially are responsible for asking the Who, What, When, Where, and How can we assist questions. They are the front-lines of the business, so they must have excellent customer service skills, be able to type without looking at the key board with a low error rate.

https://www.indeed.com/viewjob?t=qa+complaint+specialist&jk=799a5181abb5988c&_ga=2.247811456.640713282.1560794882-1429968906.1557248850

Regulatory Affairs Analyst - San Rafael, CA - KatalystHLS

Support the Global Regulatory Policy Team in the following regulatory policy activities: Review and inform on recently published global regulatory legislation and policies impacting development of treatments for rare diseases. Provide project management support to the policy team in generation of comments on draft guidances. Track Team memberships and involvement in policy trade associations and organizations Actively monitor and track policy meetings, track policy team activities and reports, track relevant policies and regulations.

https://www.indeed.com/viewjob?t=regulatory+affairs+analyst&jk=037183f127b86a68&_ga=2.45844643.640713282.1560794882-1429968906.1557248850

Quality Compliance Specialist II - San Francisco, CA - Indeed.com

The Product Quality Surveillance Senior Specialist – Commercial Complaints is an experienced Quality and Technical professional who delivers the Product Quality Surveillance activities for Takeda\'s pipe-line products and appropriate support for in-line products to enable a sustainable existence on the market. Product Quality Surveillance Senior Specialist works closely and collaboratively with the Product Quality Management Leads, Technical Operations and other Takeda functions / stakeholders across the Business to execute product quality surveillance strategies, specifically Product Quality Complaint administration.

https://www.indeed.com/viewjob?t=quality+compliance+specialist+ii&jk=8de89e85d2c1f757&_ga=2.248146944.640713282.1560794882-1429968906.1557248850

Process Documentation Writer - Boston, MA - KatalystHLS.com

Responsible for GMP documentation process in support of manufacturing operations including: Initiate and revise SOPs, Batch Records and Form Preps. Ensure documents are reviewed periodically to meet or exceed compliance expectations Identify and lead required documentation revisions Address Next Revision Suggestion Form (NRSF) items Provide expertise and leverage best practices to technicians and support groups when reviewing draft SOPs and Batch Records/Form Preps

https://www.indeed.com/viewjob?t=process+documentation+writer&jk=8ab2320760da9b6d&_ga=2.7506101.640713282.1560794882-1429968906.1557248850

Process Documentation Writer - Boston, MA - IKatalystHLS

Responsible for GMP documentation process in support of manufacturing operations including: Initiate and revise SOPs, Batch Records and Form Preps. Ensure documents are reviewed periodically to meet or exceed compliance expectations Identify and lead required documentation revisions Address Next Revision Suggestion Form (NRSF) items Provide expertise and leverage best practices to technicians and support groups when reviewing draft SOPs and Batch Records/Form Preps

https://www.indeed.com/viewjob?t=process+documentation+writer&jk=8ab2320760da9b6d&_ga=2.7506101.640713282.1560794882-1429968906.1557248850

LABORATORY TECH III (Client: Allergan) - San Antonio, TX - KatalystHLS.com

Duties to include testing wet and physical chemistry testing of raw materials, In-process bulks, and finished products according to company and proprietary procedures. Preparation and analysis of sample and standard solutions, maintaining laboratory notebook and testing documentation, compliance with regulatory requirements in the pharmaceutical field.

https://www.indeed.com/viewjob?t=laboratory+tech+iii+client+allergan&jk=f5d3c6380a511543&_ga=2.54357039.640713282.1560794882-1429968906.1557248850

Principal SAS Programmer - Princeton, NJ - katalysthls.com

Convert study design and specifications into programs to support clinical trials. Validate S A S programs written by others. Assists Management in maintaining SOPS and work instructions relevant to S A S programming. Follow regulatory requirements and guidelines for the development, usage, and maintenance of programs to support regulatory submissions. Disseminate the programming activities for a clinical trial to a junior level. Write and maintain documentation to describe program development, logic, coding, testing, and updating.

https://www.indeed.com/viewjob?t=principal+sas+programmer&jk=00fd2429c9147e8d&_ga=2.199772206.1883655580.1560177893-1429968906.1557248850

Quality Control Manager - Bordentown, NJ - katalysthls.com

The QC Manager, Microbiology oversees the Microbiology department to ensure compliance with SOPs, cGMP, USP, and EU regulations by all personnel. Assists with the development and implementation of policy and directs and administers day-to-day Microbiology activities, such as sampling, training, and testing. Trending of environmental sampling and implementing corrective and preventative plans of action for any out of trend occurrences

https://www.indeed.com/viewjob?t=quality+control+manager&jk=a181d951b7a2a706&_ga=2.128639884.1883655580.1560177893-1429968906.1557248850

Clinical Data Manager - Township of Lawrence, NJ

Serve as the client DM team member on the client study team and as the sponsor DM representative on the client-CRO study team. Provide direct oversight to the CRO during study start-up, maintenance, and lock ensuring the protocol is being followed. Review of external vendor data including bio-marker data. Review of Medidata Rave e Dc generated data.

https://www.indeed.com/viewjob?t=clinical+data+manager&jk=e8f39dbf77c2b146&_ga=2.195759148.1883655580.1560177893-1429968906.1557248850

Regulatory Publishing Specialist - Bridgewater, NJ - KatalystHLS.com

The Regulatory Operations Specialist is responsible for the timely preparation of submission ready components, assisting with publishing of global regulatory submissions and archiving of regulatory correspondence/submissions. They will produce submission-ready documents, with emphasis on meeting company and health authority standards.

https://www.indeed.com/viewjob?t=regulatory+publishing+specialist&jk=d13792e41b3b7178&_ga=2.3885104.1883655580.1560177893-1429968906.1557248850

Regulatory Publishing Specialist - Bridgewater, NJ KatalystHLS.com

The Regulatory Operations Specialist is responsible for the timely preparation of submission ready components, assisting with publishing of global regulatory submissions and archiving of regulatory correspondence/submissions. They will produce submission-ready documents, with emphasis on meeting company and health authority standards. They will also provide publishing support for electronic and paper regulatory submissions in accordance with global health authority standards.

https://www.indeed.com/viewjob?t=regulatory+publishing+specialist&jk=d13792e41b3b7178&_ga=2.238822400.1883655580.1560177893-1429968906.1557248850

SAS Programmer - New Brunswick, NJ

The Senior Analyst SAS Programmer, will partner closely with colleagues from the broader organization to extract raw data from servers, create analytical data files, and execute statistical analyses based on protocol specifications. The successful candidate\'s responsibilities will include overseeing and implementing analyses against in-house observational data resources, including administrative healthcare claims, surveys, and electronic health records, as well as consultation and support to evaluate data external to J&J.

https://www.indeed.com/viewjob?t=sas+programmer&jk=e7892a3955200559&_ga=2.204163088.1883655580.1560177893-1429968906.1557248850

Quality Engineer - Austwell, TX

Hands on experience in Risk management (DFMEA, PFMEA, risk analysis) , Analytics/statistical techniques, Requirements management, Verification & Validation. Hands on experience in Medical device Quality Management system (QMS) Design control across the lifecycle of the product.

https://www.indeed.com/viewjob?t=quality+engineer&jk=2022bd8b79812ba3&_ga=2.163309372.1883655580.1560177893-1429968906.1557248850

Regulatory Publishing Specialist - Boston, MA

The Regulatory Operations Specialist is responsible for the timely preparation of submission ready components, assisting with publishing of global regulatory submissions and archiving of regulatory correspondence/submissions. They will produce submission-ready documents, with emphasis on meeting company and health authority standards. They will also provide publishing support for electronic and paper regulatory submissions in accordance with global health authority standards. The Regulatory Publishing Specialist must demonstrate the ability to work independently and manage multiple priorities.

https://www.indeed.com/viewjob?t=regulatory+publishing+specialist&jk=18a2c273dfa1bed6&_ga=2.162605116.1883655580.1560177893-1429968906.1557248850

Regulatory Publishing Specialist - Foster City, CA

The Regulatory Operations Specialist is responsible for the timely preparation of submission ready components, assisting with publishing of global regulatory submissions and archiving of regulatory correspondence/submissions. They will produce submission-ready documents, with emphasis on meeting company and health authority standards. They will also provide publishing support for electronic and paper regulatory submissions in accordance with global health authority standards.

https://www.indeed.com/viewjob?t=regulatory+publishing+specialist&jk=a2a11d356b1a4ec8&_ga=2.200470318.1883655580.1560177893-1429968906.1557248850

Drug Safety Specialist - Clearmont, WY

Monitors the Clinical SAE and Post-marketing mailbox Assesses and triages the reportable ADEs and ADRs for completeness and ensures they are legible for processing Documents and forwards ADEs and ADRs to Safety CRO for processing Performs reconciliation of the ADEs and ADRs receipt with vendor sites, safety CROs, DSO and Alexion affiliates

https://www.indeed.com/viewjob?t=drug+safety+specialist&jk=2b19d790cb4304ee&_ga=2.241772674.1883655580.1560177893-1429968906.1557248850

SAS Programmer - New Brunswick, NJ

The position will be primarily responsible for developing code sets for team approval, creating data specification files and analytical files by writing and executing programs across our available observational databases, executing statistical analyses conducting quality assurance and code validation, reviewing programming code and data, drafting analysis reports, and supporting the final publication/presentation of results as part of an overall observational study.

https://www.indeed.com/viewjob?t=sas+programmer&jk=e7892a3955200559&_ga=2.247843909.378437399.1558387801-1429968906.1557248850

Validation Engineer II - Somerville, NJ

Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements. Pharmaceutical principles, practices and applications. English usage, spelling, grammar and punctuation. Principles of mathematical and statistical computations.

https://www.indeed.com/viewjob?t=validation+engineer+ii&jk=96e8d084590c21c5&_ga=2.176670951.378437399.1558387801-1429968906.1557248850

Regulatory Submission Publisher - Bridgewater, NJ

Minimum 4 years of eCTD publishing experience required Experience in eCTD publishing for low/medium complexity in one or more ICH region Experienced with IND and NDA eCTD submissions. Submission publishing includes creating navigation in PDF document Clinical study report, CRF processing, word formatting and publishing of eCTD, NeeS and Paper Experience with mainstream publishing tools (e.g. Insight publisher or DocuBridge or eCTDXpress)

https://www.indeed.com/viewjob?t=regulatory+submission+publisher&jk=7ed43e2cabece832&_ga=2.184468324.378437399.1558387801-1429968906.1557248850

Regulatory Submission Publisher - Bridgewater, NJ

Minimum 4 years of eCTD publishing experience required Experience in eCTD publishing for low/medium complexity in one or more ICH region Experienced with IND and NDA eCTD submissions. Submission publishing includes creating navigation in PDF document Clinical study report, CRF processing, word formatting and publishing of eCTD, NeeS and Paper Experience with mainstream publishing tools (e.g. Insight publisher or DocuBridge or eCTDXpress)

https://www.indeed.com/viewjob?t=regulatory+submission+publisher&jk=7ed43e2cabece832&_ga=2.184468324.378437399.1558387801-1429968906.1557248850

SAS Programmer - New Brunswick, NJ

The position will be primarily responsible for developing code sets for team approval, creating data specification files and analytical files by writing and executing programs across our available observational databases, executing statistical analyses conducting quality assurance and code validation, reviewing programming code and data, drafting analysis reports, and supporting the final publication/presentation of results as part of an overall observational study.

https://www.indeed.com/viewjob?t=sas+programmer&jk=e7892a3955200559&_ga=2.156692345.378437399.1558387801-1429968906.1557248850

Sales Specialist, Pharma Products - Home Based - Katalyst HLS

Sales Specialist, Pharma Products - Home Based - KatalystHLS.com Our Client is a pharmaceutical company with wide variety of niche products in R&D pipeline and ready to launch, seeking the services of a dynamic, personable, “can-do\" sales specialist who is capable of taking new and niche pharma products into market. Contact: info@KatalystHLS.com; Careers@KatalystHLS.com #OTC #Sales #FDA #Pharma #KatalystHLS #RemoteJobs #HomeBasedJobs

https://www.indeed.com/viewjob?t=sales+specialist+pharma+products&jk=69eef7a2421a1ed1&_ga=2.224547865.2055221573.1559691507-2073862758.1558201441

Clinical SAS Programmer - New Brunswick, NJ - Katalyst HLS

Clinical SAS Programmer - New Brunswick, NJ - KatalystHLS.com Overseeing and implementing analyses against in-house observational data resources, including administrative healthcare claims, surveys, and electronic health records, as well as consultation and support to evaluate external data. #KatalystHLS #SAS #Jobs #OPT #CPT #H4EAD #F1 #Remote

https://www.indeed.com/viewjob?t=sas+programmer&jk=e7892a3955200559&_ga=2.226752542.2055221573.1559691507-2073862758.1558201441

LIMS Validation Analyst - Brooklyn, NY - Katalyst HLS

LIMS Validation Analyst - Brooklyn, NY - KatalystHLS.com Experience with configuration, customization of LIMS COTS like Labware, WinLIMS LIMS LINK , EMPOWER and Chemstation etc. #KatalystHLS #Jobs #FDA #LIMS #Validation #CSV #cGMP #cGxP

https://www.indeed.com/viewjob?t=lims+analyst&jk=ebb28d1dcaaeebea&_ga=2.224547865.2055221573.1559691507-2073862758.1558201441

LIMS Validation Analyst - Brooklyn, NY - Katalyst HLS

LIMS Validation Analyst - Brooklyn, NY - KatalystHLS.com Experience with configuration, customization of LIMS COTS like Labware, WinLIMS LIMS LINK , EMPOWER and Chemstation etc. #KatalystHLS #Jobs #FDA #LIMS #Validation #CSV #cGMP #cGxP

https://www.indeed.com/viewjob?t=lims+analyst&jk=ebb28d1dcaaeebea&_ga=2.224547865.2055221573.1559691507-2073862758.1558201441

Sales Specialist, Optical Products - Home Based - Katalyst HLS

Sales Specialist, Optical Products - Home Based - KatalystHLS.com Our Client is a pharmaceutical company with wide variety of niche Optical products in R&D pipeline and ready to launch, seeking the services of a dynamic, personable, “can-do\" sales specialist who is capable of taking new and niche Optical products into market. Contact: info@KatalystHLS.com; Careers@KatalystHLS.com #OTC #Sales #FDA #Pharma #KatalystHLS #RemoteJobs #HomeBasedJobs #Optical #Ophthalmic #Eye

https://www.indeed.com/viewjob?t=sales+specialist+optical+products&jk=493285228884d701&_ga=2.156914744.2055221573.1559691507-2073862758.1558201441

Sales Specialist, OTC Products - Home Based - Katalyst HLS

Sales Specialist, OTC Products - Home Based - KatalystHLS.com Our Client is a Pharmaceutical Company with wide variety of niche OTC pharma products in R&D pipeline and ready to launch, seeking the services of a dynamic, personable, “can-do\" sales specialist who is capable of taking new and niche OTC pharma products into market. Contact: info@KatalystHLS.com; Careers@KatalystHLS.com #OTC #Sales #FDA #Pharma #KatalystHLS #RemoteJobs #HomeBasedJobs

https://www.indeed.com/viewjob?t=sales+specialist+otc+products&jk=f369c7de7478f740&_ga=2.120347403.2055221573.1559691507-2073862758.1558201441