• Quality Specialist

    Insight Global (Horsham, PA)


    Job Description

    One of our large pharmaceutical clients is looking to hire a remote Quality Specialist to join the EQ team. The individual will provide QA support for External Manufacturers of aseptic filing and secondary packaging. They will perform assigned duties and collaborate with cross-functional teams to maintain regulatory standards, facilitate communication within the core team, and help to ensure that all quality-related activities project goals and deadlines are met.

     

    In particular, the specific tasks required on a daily basis by the position are below, and this role will heavily support deviation management, and change control assessments.

     

    Support, review/pre-review, and/or approve the following -

     

    -EM Quality Events

     

    -EM CAPAs

     

    -EM Change Controls

     

    -EM Planned Deviations

     

    -Batch record review

     

    -EM Product Quality Complaints

     

    -EM Protocols

     

    -EM Risk Assessments

     

    -EM Electronic Batch Record (eBR) changes

     

    -EM Manufacturing Process Instruction (MPI) changes

     

    Own/support the following

     

    -Own and execute change control activities

     

    -Own/support internal Nonconformances (NC) in Comet

     

    -Own/support internal Investigations in Comet

     

    -Own/support internal Supplier Investigations in Comet

     

    Help maintain/manage/keep organized the following

     

    -Outstanding EM issues

     

    -Transfer of document to the EM

     

    -Status of lots/production schedule

     

    -Various workstreams (help build templates, flowcharts, etc.)

     

    We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

     

    To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .

     

    Skills and Requirements

     

    Bachelor degree in Scientific field

     

    Minimum 5+ years of experience working with GMP pharmaceutical manufacturing

     

    Expertise handling review and approval of deviation management, batch record review, Change Controls, deviations, quality product complaints, product risk assessments

     

    Experience with aseptic techniques

     

    Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.

     

    Excellent computer proficiency e.g MS Office, Teams, and SharePoint, QuickBase, Quality Management Systems (including documentation, non-conformance, change control, etc.)

     

    Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.

     

    A motivated individual with the ability to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude. Experience working with external partners, preferably CMO partnerships

     

    Experience working within secondary packaging

     

    Experience with Regulatory and Health Authority GMP responses and documentation requirements

    Comet Quality System experience null

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].