Jobs
>
New Brunswick

    Scientist, Document Control - New Brunswick, NJ, United States - Yoh

    Yoh
    Yoh New Brunswick, NJ, United States

    3 weeks ago

    Default job background
    Description
    12 month W2 contract (with potential to extend or transition to perm)

    Pay rate:
    $70-79/hour - Depending on Education and Experience


    The Principal Scientist Stability is responsible for stability product strategy and oversight of product stability programs for commercial small molecules Drug Substances and Drug Products Oral and Sterile.

    Activities include those associated with product stability strategy, stability program requirements, authoring / approving stability protocols, and preparation, review and approval of stability reports and regulatory filings.


    The Principal Scientist stability is accountable for the stability program on assigned brand (s) and acts as Stability Product Lead.


    Participates on transfer team for new products to internal and external sites (as required), reviews registrational stability studies and conducts gap analysis against Global Manufacturing & Supply requirements.

    Develops stability data where gaps exist.
    Develops and maintains expertise on the overall stability performance of products manufactured in the global supply chain, including maintaining a working knowledge of the attributes that impact the products' performance/stability profile
    Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change
    Perform change control impact assessments and document the stability assessment in change controls. Initiate change controls related to stability operations
    Responsible for the handling of annual commercial stability program for assigned products in coordination with sample management groups.

    Serves as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards.

    Identify information regarding stability program that may impact lab capacity, product studies or regulatory commitments directly, escalate promptly to management and act as required.

    Support health authorities inspection internal and external.
    Represents department in cross functional projects
    Ensure training requirements are met.
    Acts as an advisor and mentor to stability staff
    Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents.

    A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.

    Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods.

    Very good skills to drive development of technical or scientific initiatives for solving complex problems/issues; recommending and drive science-based decisions/ implementation of solutions.

    Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles
    Good Knowledge of evaluation and interpretation of stability data using statistics software. Review data and demonstrated ability to recognize anomalous trends or results
    Significant experience on health authorities inspections on stability programs.

    Advanced ability to prioritize objectives from multiple projects and ability to adapt to quick changes in schedules in order to accommodate priority requests.

    Advanced knowledge of Microsoft office applications , LIMS, Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. Chemistry, Biology, Microbiology or relevant discipline
    Experience/Knowledge: 8 years of relevant work experience required, preferable in a Pharmaceutical environment.

    Yoh's network of client companies has been employing professionals like you for over 65 years in the U.Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.

    ~ Medical, Dental & Vision Benefits
    ~401K Retirement Saving Plan
    ~ Life & Disability Insurance
    ~ Direct Deposit & weekly ePayroll
    ~ All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

    Visit to contact us if you are an individual with a disability and require accommodation in the application process.

  • Datawize Technologies LLC

    Document Control Clerk

    5 days ago

    Datawize Technologies LLC New Brunswick, United States

    **Work Hours: 8:30-4:30** · **Lunch hours(unpaid): 1 Hour** · **Dress Code: Business casual** · **Office or Remote: office** · **location: 550 Jersey Ave. New Brunswick 08801** · **Parking: Parking available next to office** · **Job Description: · - ** · Equipment to be used by t ...

  • Bechtel

    Document Control Manager

    1 week ago

    Bechtel New York, United States

    **Requisition ID: 276097** · - ** Relocation Authorized: None**: · - ** Telework Type: Full-Time Office/Project**: · - ** Work Location: New York, NY**: · Since 1898, we have helped customers complete more than 25,000 projects in 160 countries on all seven continents that have cr ...

  • Datawize Technologies LLC

    Document Control Clerk

    2 weeks ago

    Datawize Technologies LLC Trenton, United States

    **Document Control Clerk / Filing Specialist** · **Shift Timing · - Mon-Fri from 8:30am-4:30pm** · **Lunch · - 1 hr. (unpaid)** · **Work Location · - 33 West State St 5th Floor, Trenton, NJ 08608** · **Job Description: · - ** · - General administrative/ processing forms / data en ...

  • Bwise Manufacturing Llc

    Document Control Specialist

    1 week ago

    Bwise Manufacturing Llc Chambersburg, United States

    Document control specialists will invoice, categorize, file, and retrieve documents using specific classification and organization systems. Specialists are responsible for the invoicing of trailers, orderly recording and keeping of physical and electronic documents, including dis ...

  • K&A Engineering Consulting PC

    Document Control Specialist

    3 days ago

    K&A Engineering Consulting PC New Brunswick, United States

    Header: · K&A Engineering Consulting White Plains, NY is a people-first organization. We value knowledge and learning. We believe in the power of connection, and collaboration, and we seek to build relationships that mean something. We employ some of the best and brightest in th ...

  • Codinix Technologies

    Document Control Clerk

    3 weeks ago

    Codinix Technologies Trenton, United States

    Seeking a dedicated temporary worker to complete an analysis of program files including organizing records, boxing and labeling documents in accordance with the Records Retention and Disposition Schedule. · **Job Types**: Part-time, Contract · Pay: Up to $20.00 per hour · Schedul ...

  • Bright Star Technologies

    Document Control Specialist

    3 weeks ago

    Bright Star Technologies Newark, United States

    **Responsibilities**: · ***: · - Scan large format, letter size and other size paper documents. · - Enter, edit and update data from several source documents into a the ECM system. · - Manage index information and update/modify when necessary. · - Ensure that all files follow fil ...

  • Biogensys

    Document Control Clerk

    4 days ago

    Biogensys New Brunswick, United States

    Job Description · Job DescriptionWe are hiring a Document Control Clerk / Filing Specialist for one of our clients in New Brunswick, NJ. · Job Description: · Filing, copying, collating, phones · Skills required: · Pleasant, able to deal with difficult consumers · Typing, filing, ...

  • i2Systems

    Document Control Manager

    2 days ago

    i2Systems Morris, United States

    The Document Control Manager is responsible for overseeing and managing all aspects of Document Control and Configuration Management within the organization. This role involves establishing and maintaining effective document control processes and systems to ensure the accuracy, i ...

  • PSEG

    Document Controls Manager

    5 days ago

    PSEG Newark, United States

    **Requisition**: 78399 · **PSEG Company**: Public Service Electric & Gas Co. · **Salary Range**: $ 101,600 - $ 160,900 · **Incentive**: PIP 15% · **Work Location Category**: Hybrid · PSEG operates under a Flexible Work Model where flexible work is offered when job requirements al ...

  • OCI Global

    Document Control Supervisor

    1 week ago

    OCI Global Nederland, United States

    At OCI GIobal, we realize the greatest and most exciting opportunities to drive change and unlock a more secure and sustainable future for us all. · We are a world-leading producer and distributor of hydrogen-based products, and lower-carbon fertilizers, fuels and feedstock. Thro ...

  • PSEG

    Document Controls Manager

    3 days ago

    PSEG Newark, United States

    **Requisition**: 78680 · **PSEG Company**: Public Service Electric & Gas Co. · **Salary Range**: $ 101,600 - $ 160,900 · **Incentive**: PIP 15% · **Work Location Category**: Hybrid · PSEG operates under a Flexible Work Model where flexible work is offered when job requirements al ...

  • Newkleo LLC

    Document Control Clerk

    1 week ago

    Newkleo LLC Trenton, United States

    Placing file records in order, purging files to be taken off site, placing file numbers into a spreadsheet · - Brief Responsible with placing district file records into filing stacks · **Skills required**: · - Able to place files into chronological and numerical order while stepp ...

  • ProStaff Solutions Inc

    QA Documentation Control Associate

    5 days ago

    ProStaff Solutions Inc New Brunswick, United States

    Job Description · Job DescriptionWe are seeking a detail-oriented and organized QA Documentation Control Associate to join our client's team in New Brunswick, New Jersey. The Documentation Associate provides administrative support within Office of Data Reliability (ODR). He/she i ...

  • ProStaff Solutions Inc

    QA Documentation Control Associate

    1 week ago

    ProStaff Solutions Inc New Brunswick, United States

    Job Description · Job DescriptionWe are seeking a detail-oriented and organized QA Documentation Control Associate to join our client's team in New Brunswick, New Jersey. The Documentation Associate provides administrative support within Office of Data Reliability (ODR). He/she i ...

  • Newkleo LLC

    Document Control Filing Specialist

    1 week ago

    Newkleo LLC Trenton, United States

    Perform work tracking services, set up invoice sessions on oracle system for expedited and regular work. · - Monitors payments, initiate follow-up action to secure the determined amount due. · - Create a session for work received · - Process transactions via credit card, checks, ...

  • PSG Global Solutions Careers

    Document Control

    1 week ago

    PSG Global Solutions Careers Bedminster, United States

    Apply now and our proprietary system will quickly have you in front of a live recruiter. · The Opportunity · Description · We're looking for a Document Control, working in Biotechnology/Medical Devices industry in Bedminster, New Jersey, 07921, United States. · Job descriptio ...

  • First Class Moving Systems

    Document Control Coordinator

    2 weeks ago

    First Class Moving Systems Bound Brook, United States

    Job Description · Job DescriptionSalary: $20-$24hr DOE · This is a seasonal position lasting from April to August/September · Document Control Coordinator · At First Class Moving Systems, an agent for North American Van Lines, our mission is to provide quality-focused, customer-c ...

  • Mace

    Document Controller

    9 hours ago

    Mace New York City, United States Full time

    Position Status: This opportunity is for a secured role that is due to commence in March subject to approval. If you would like to be considered as we progress with this position, please click to apply. · At Mace, our purpose is to redefine the boundaries of ambition. We believe ...

  • Client

    Document Controller

    1 week ago

    Client New York, United States Full time

    Document Controller · Salary: $52,000 - $81,000 (DOE) + Bonuses + Medical Benefits · New York (Brooklyn/Manhattan) · Are you a Document Controller eager to make a significant impact on major public and private projects? · Are you looking to join a company that is looking to exp ...