Compliance Microbiology Reviewer

3 weeks ago


Hunt Valley, Maryland, United States Pharmaceutics International Inc Full time
Job Overview:

Pharmaceutics International Inc is seeking a Compliance Microbiology Reviewer to join our team. The Compliance Microbiology Reviewer will be responsible for reviewing microbiology data and associated documentation to ensure compliance with company policies, procedures, and specifications as well as with local, state, federal, and international regulations.

About the Role:
The Compliance Microbiology Reviewer will review microbiology testing data, including endotoxin, sterility, microbial enumeration, specified microorganisms, bioburden, particulate matter, environmental and personnel monitoring, and water testing. The role will also involve authoring, reviewing, and supporting validation protocols, reports, and associated data.

Key Responsibilities:
  • Review microbiology testing data, including endotoxin, sterility, microbial enumeration, specified microorganisms, bioburden, particulate matter, environmental and personnel monitoring, and water testing.
  • Data review of multiple sample types, including raw material, stability, finished product, in-process, clinical material, and packaging components.
  • Author, review, and support for validation protocols, reports, and associated data, including microbiology method verification/validation, equipment qualification, aseptic process simulation, and research and development.

Requirements:
  • Bachelor's degree or higher in Microbiology, Biology, or other Science, or equivalent combination of education, training, and professional experience.
  • Minimum of 5 years of relevant work experience in Microbiology or data review of Microbiology in the pharmaceutical industry.
  • Experience in CMO/CDMO, clinical, and commercial products is preferred.
  • Solid understanding of current federal and international regulations regarding production, testing, and release of drug products.

What We Offer:
We offer a competitive salary of $90,000 - $120,000 per year, depending on experience, as well as a comprehensive benefits package, including health insurance, retirement plan, and paid time off.

  • Hunt Valley, Maryland, United States Pharmaceutics International Inc Full time

    About the Job:Pharmaceutics International Inc is seeking a highly skilled Microbiology Analyst to join our team. The successful candidate will be responsible for reviewing microbiology data and associated documentation to ensure compliance with company policies, procedures, and specifications as well as with local, state, federal, and international...

  • QC Microbiologist

    4 weeks ago


    Hunt Valley, Maryland, United States Pharmaceutics International Inc Full time

    Job Description:Job Summary:We are seeking a highly skilled QC Microbiologist - Compliance Expert to join our team at Pharmaceutics International Inc. As a key member of our quality control department, you will play a critical role in ensuring the quality and safety of our products.About the Role:The QC Microbiologist - Compliance Expert will be responsible...


  • Hunt Valley, Maryland, United States Pharmaceutics International Inc Full time

    Job Overview:The QC Micro Compliance position is responsible for review of QC-Microbiology data and associated documentation to ensure compliance with company policies, procedures, and specifications as well as with local, state, federal, and international regulations.Responsibilities:Review Microbiology testing data, including but not limited to the...

  • Quality Lab Associate

    1 month ago


    Hunt Valley, United States System One Full time

    Job Title: Quality Lab Associate Location: Hunt Valley, MD Schedule: Monday-Friday 8am-5pm Pay Rate: $20-$22/hr Type: 6 Month Contract Start Date: ASAP Responsibilities: Support implementing PCR testing across multiple sites for expiration date verification Review data from various labs to compare PCR results with other expiration date...


  • Hunt Valley, United States Express Employment Full time

    Job DescriptionJob DescriptionLocated in Hunt Valley, MDSalary: $125-185KSpecialized Recruiting Group is seeking a Construction Project Manager to fill an immediate opening in Cockeysville, MD!ResponsibilitiesReview and monitor design and construction documents for budget, schedule, and contract compliance.Foster client relationships and maintain effective...


  • VALLEY FALLS, United States Centene Full time

    You could be the one who changes everything for our 28 million members. Centene is transforming the health of our communities, one person at a time. As a diversified, national organization, you’ll have access to competitive benefits including a fresh perspective on workplace flexibility. Applicants for this job have the flexibility to work remote from home...


  • Golden Valley, United States Room & Board Full time

    OverviewAre you passionate about sustainability and compliance? Do you thrive in dynamic environments where your efforts directly contribute to a better planet and community? If so, join our team as a Product Compliance Specialist and play a pivotal role in advancing our sustainability goals.In this exciting new role, you'll collaborate on innovative...


  • Golden Valley, United States Moments Hospice Full time

    Job DescriptionJob DescriptionJob Description SummaryThe QAPI and Regulatory Compliance RN is responsible for QAPI process for assigned agencies. The QAPI and Regulatory Compliance RN is responsible for ensuring that assigned offices are complying with the Community Health Accreditation Partner (CHAP) standards, Center for Medicare and Medicaid Services...


  • Hunt Valley, United States Bank of America Full time

    Global Financial Crimes Sr. Investigator Charlotte, North Carolina;Tampa, Florida; Pennington, New Jersey; Hunt Valley, Maryland; Farmington, Connecticut; Phoenix, Arizona; Chicago, Illinois Job Description: At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is...


  • Jurupa Valley, United States Crane Co. Full time

    Position Summary:The IT Compliance Manager will be responsible for leading all IT compliance activities at the site, including System Security Plan (SSP), Plan of Action and Milestones (POAM), and Sarbanes-Oxley Act (SOX) compliance. They will oversee the development and maintenance of SSPs, ensuring alignment with regulatory requirements and organizational...

  • Quality Engineer II

    6 days ago


    Hunt Valley, United States Textron Full time

    Quality Engineer II Description Job Summary: Performs Quality Engineering assignments for the Electronic Systems domain requiring independent evaluation, selection, and application of standard Quality Engineering techniques, procedures, and criteria using judgment and ingenuity in making adaptations and modifications. Work is performed on moderately...


  • Hunt Valley, United States Robert Half Full time

    DescriptionWe are seeking an Attorney/Lawyer to join our investment advisory firm located in HUNT VALLEY, Maryland. In this role, you'll work closely with various teams and clients, focusing on estate planning and trust administration. This role offers an exciting opportunity to provide legal advice and manage estate planning for high-net-worth individuals...


  • hunt valley, United States Normann Staffing Services Full time

    Job Title: Aseptic Manufacturing ManagerHours: 3rd shift - Sunday-Thursday 11 PM-8 AMJob Type: Full time, direct hire position with benefitsLocation: Hunt Valley, MDJob Responsibilities:Provide leadership to Aseptic Manufacturing Associates which includes hiring, managing, motivating, coaching, and mentoring.Support Aseptic Manufacturing operations across...


  • Hunt Valley, United States Normann Staffing Services Full time

    Job Title: Aseptic Manufacturing ManagerHours: 3rd shift - Sunday-Thursday 11 PM-8 AMJob Type: Full time, direct hire position with benefitsLocation: Hunt Valley, MDJob Responsibilities:Provide leadership to Aseptic Manufacturing Associates which includes hiring, managing, motivating, coaching, and mentoring.Support Aseptic Manufacturing operations across...


  • Hunt Valley, United States Normann Staffing Services Full time

    Job Title: Aseptic Manufacturing ManagerHours: 3rd shift - Sunday-Thursday 11 PM-8 AMJob Type: Full time, direct hire position with benefitsLocation: Hunt Valley, MDJob Responsibilities:Provide leadership to Aseptic Manufacturing Associates which includes hiring, managing, motivating, coaching, and mentoring.Support Aseptic Manufacturing operations across...

  • Staff Accountant

    2 days ago


    Hunt Valley, United States Your Trusted CFO LLC Full time

    Job DescriptionJob DescriptionJob descriptionThe Staff Accountant at Your Trusted CFO, a fractional accounting firm, will play a crucial role in providing high-quality accounting services to a diverse client base. This role involves maintaining accurate financial records, preparing financial reports, and ensuring compliance with accounting standards and...


  • Fountain Valley, United States UCI Health Full time

    DetailsClient Name UCI Health - Fountain Valley Job Type Travel Offering Nursing Profession RN Specialty Case Manager Job ID 29263186 Job Title UTILIZATION REVIEW RN Case Manager Weekly Pay $3139.0 Shift DetailsShift Day - 8x5 - 08AM Scheduled Hours 40 Job Order DetailsStart Date 11/18/2024 End Date 02/15/2025 Duration 13 Week(s) Job Description Job Title:...


  • Hunt Valley, United States AssuredPartners Full time

    Overview We are hiring for a Mid-Market Employee Benefits Account Executive. This role will handle the day-to-day operations of clients' insurance needs and work with various team members to deliver proper insurance and risk management services for clients. The Ideal Candidate You have strong critical thinking skills and focus on accuracy You enjoy...


  • Hunt Valley, United States Hilb Group Full time

    Overview: Grow With Us! At Hilb Group, we recognize that our associates are our greatest asset. We promote a service-driven culture of high performance that encourages career and professional development. The Hilb Group is currently seeking a motivated and ambitious Benefits Consultant to join our team. This position will report to our agency located in Hunt...

  • Director Compliance

    1 week ago


    Spring Valley, United States P4P Team Full time

    Job DescriptionJob DescriptionJob descriptionMUST HAVE LAW DEGREE (or equivalent)Job Overview: The role of Director of Compliance Officer is to analyze, develop and implement Compliance initiatives including the monitoring of and evaluation ofthe compliance of all programs and to assist in facilitating and ensuring the implementation of all relevant federal,...


  • Hunt Valley, United States Greater Baltimore Medical Center (GBMC) Full time

    Under general supervision, acts as palliative medicine consultant in various settings, including hospital, nursing facility and home. Makes recommendations for care plans, symptom management and goals of care. Works in collaboration with staff and attending physicians within care settings. Education: Successful completion of a Nurse Practitioner program;...


  • Hunt Valley, United States Bank of America Full time

    Fraud Servicing ATM Debit English - 2nd Shift Hunt Valley, Maryland Job Description: At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. We do this by driving Responsible Growth and delivering for our clients, teammates, communities and shareholders every day. Being a Great...


  • hunt valley, United States Knollwood Investment Advisory Full time

    Knollwood Investment Advisory is a global investment firm outside of Baltimore, MD. The firm was founded in 1990 and activelyinvests across publicequities, credit, real assets, privateequity, and venture capital. Knollwood’s venture platform consists of fund, direct, and secondary investment strategies that follow a disciplined approach to identifying...