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QC Microbiologist - Onsite

AT Cencora
Cencora

QC Microbiologist - Onsite

Columbus, OH

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

The QC Microbiologist will focus on Quality Control microbiological testing at AHP and work closely with other departments within the Quality Unit to ensure drug product meets all standards.

This job is compliance critical and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements

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PRIMARY DUTIES AND RESPONSIBILITIES:

  • Ensure Quality Control activities are compliant with FDA, DEA, other regulatory body requirements as applicable. Ensure compliance with local and corporate policies and procedures.
  • Perform microbiological testing for drug products in accordance with compendial and global requirements, as applicable.
  • Perform environmental monitoring sampling and testing for controlled manufacturing areas.
  • Develop, revise, and review standard operating procedures (SOPs), work instructions (WIs), and test method documents to ensure compliance with applicable compendia and regulations.
  • Assist in the support of manufacturing operations including process validation, environmental monitoring, and utilities as applicable.
  • Perform review and release of microbial tests for compliance to SOPs and regulatory requirements and ensure data is reported accurately.
  • Prepare lab reports as required.
  • Assist with root cause investigations for quality incidents related to microbiology or environmental monitoring.
  • Maintain Quality System records and ensure completeness and accuracy.
  • Coordinate with department management to identify and implement compliant process improvements.
  • Clarify regulations, policies, and procedures to internal teams as applicable.
  • Coordinates with departmental leaders to develop appropriate corrective actions resulting from investigations, internal audits, and facility inspections.
  • Conduct follow-up checks on the effectiveness of corrective actions
  • Performs other duties to support Quality Systems and Regulatory Affairs department as assigned.

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

Bachelor's degree in microbiology or biological sciences required. Three or more years' experience within a pharmaceutical manufacturing (cGMP) laboratory environment. Should have a working knowledge of pharmaceutical manufacturing requirements, Quality System principles (Documentation, Training, Investigations/CAPA, Change Control, etc), and global Quality Control regulations.

Experience with MasterControl or other electronic quality management system preferred.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

  • Good oral, written, communication, and interpersonal skills.
  • Ability to develop and maintain cooperative working relationships with others.
  • Effectively interfaces with multiple levels of associates within the organization, including management and plant associates.
  • Ability to work independently.
  • Ability to handle a variety of tasks simultaneously.
  • Attention to detail.
  • Familiarity with concepts of electronic documentation management systems (EDMS).

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated Companies

Affiliated Companies: AmerisourceBergen Drug Corporation

Client-provided location(s): Columbus, OH, USA
Job ID: Cencora-R2420656
Employment Type: Full Time

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Health Reimbursement Account
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA With Employer Contribution
    • HSA
    • HSA With Employer Contribution
    • FSA
    • On-Site Gym
    • Pet Insurance
    • Mental Health Benefits
  • Parental Benefits

    • Birth Parent or Maternity Leave
    • Non-Birth Parent or Paternity Leave
    • Adoption Leave
    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
  • Work Flexibility

    • Remote Work Opportunities
    • Flexible Work Hours
    • Hybrid Work Opportunities
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Personal/Sick Days
    • Leave of Absence
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K)
    • 401(K) With Company Matching
    • Stock Purchase Program
    • Financial Counseling
  • Professional Development

    • Internship Program
    • Promote From Within
    • Access to Online Courses
    • Tuition Reimbursement
    • Lunch and Learns
  • Diversity and Inclusion

    • Employee Resource Groups (ERG)
    • Diversity, Equity, and Inclusion Program

Company Videos

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