Top 39 Microbiology Jobs in Willoughby, Oh

Batch Record Reviewer
Hikma Pharmaceuticals PLC —Bedford, OH
- $45,000 - $75,000 a year
- Full-time
- Bachelor of Science
- Data analysis skills
- Mid-level
- Paid parental leave
- Paid holidays
Quick Apply
1d
Part-Time Laboratory Technologist (MLT)
WellStreet Urgent Care —Willoughby, OH
- Overtime
- HIPAA
- Mid-level
- Associate's degree
- 401(k) matching
- Flexible schedule
Quick Apply
7d
Medical Technologist/MLT/Lab Technician - Clinical Microbiology
Cleveland Clinic —Cleveland, OH
- $34.00 - $45.65 an hour
- 8 hour shift
- Mid-level
- Bachelor's degree
- Training & development
- Health insurance
- Dental insurance
2h
Consultant, Scientific and Laboratory Informatics
Accenture —Cleveland, OH
- $59,100 - $205,800 a year
- Full-time
- Computer Science
- Up to 50% travel
- System design
- Paid holidays
- Disability insurance
Lab Team Leader - Microbiology
Cleveland Clinic —Cleveland, OH
- $69,600.00 - $106,132.50 a year
- Full-time
- 5 years
- Mid-level
- Bachelor's degree
- Health insurance
- Dental insurance
Infection Preventionist-TriPoint
University Hospitals —Concord, OH
- $74,090 - $115,898 a year
- On call
- Nursing
- RN License
- Hospital
Infection Preventionist I
Cleveland Clinic —Mentor, OH
- $63,250.00 - $96,467.50 a year
- Full-time
- Nursing
- RN License
- Hospital
- Health insurance
- Dental insurance
1d
Histopathology Technologist (Lab Information Manager)
US Veterans Health Administration —Cleveland, OH
- $116,606 - $151,591 a year
- Online Application
- Background check
- Pass drug screening
- English
3d
Medical Supply Technician (Sterile Processing)
US Veterans Health Administration —Cleveland, OH
- $56,577 - $73,549 a year
- Online Application
- Hybrid work
- Background check
- Anatomy knowledge
- Surgery
- Paid parental leave
- Paid holidays
GxP Lab Computing Analyst
Zifo —Beachwood, OH
- $75,000 - $80,000 a year
- Full-time
- Hybrid work
- Computer science
- Computer Science
- Bachelor of Science
- Health insurance
- Dental insurance
Quick Apply
7d
Medical Technologist/MLT/Lab Technician IV - Clinical Microbiology
Cleveland Clinic —Cleveland, OH
- $30.00 - $41.65 an hour
- Full-time
- Bachelor's degree
- Training & development
- Senior level
- Health insurance
- Dental insurance
2h
Research Assistant 3
Case Western Reserve University —Cleveland, OH
- $46,035 - $58,234 a year
- Extended hours
- Maintenance
- Mid-level
- 3 years
- Health insurance
- Tuition reimbursement
9d
Histotechnologist - Immunohistochemistry
Cleveland Clinic —Cleveland, OH
- $34.00 - $45.65 an hour
- Full-time
- Hospital
- Mid-level
- Bachelor's degree
- Dental insurance
- Vision insurance
9d
Senior Director, Global Gas Technology
Steris —Mentor, OH
- $167,450 - $216,700 a year
- Full-time
- Remote
- Bachelor's degree
- Travel
- Senior level
- Paid holidays
- Disability insurance
Senior Research Assistant 1
Case Western Reserve University —Cleveland, OH
- Full-time
- Bachelor of Science
- Writing skills
- Mid-level
Histotechnician/Histotechnologist
Cleveland Clinic —Cleveland, OH
- $26.25 - $36.13 an hour
- Full-time
- Mid-level
- Bachelor's degree
- 1 year
- Dental insurance
- Vision insurance
3d
Supervisory Histopathology Technologist
US Veterans Health Administration —Cleveland, OH
- $116,606 - $151,591 a year
- Online Application
- Background check
- Pass drug screening
- English
8d
Research Technician II - Awoniyi Lab
Cleveland Clinic —Cleveland, OH
- $18.88 - $28.80 an hour
- Full-time
- Mid-level
- High school diploma or GED
- 1 year
- Health insurance
- Dental insurance
14d
Quality Assurance Manager - Market Garden Brewery
Market Garden Brewery —Cleveland, OH
- $50,000 - $65,000 a year
- Email
- Microsoft Excel
- Bachelor of Science
- Laboratory experience
- Health insurance
- Paid time off
Quick Apply
9d
Management Consulting Delivery Specialist , Scientific and Laboratory Informatics
Accenture —Cleveland, OH
- $59,100 - $196,000 a year
- Full-time
- Computer Science
- Up to 50% travel
- Laboratory experience
- Paid holidays
- Disability insurance

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Batch Record Reviewer

Hikma Pharmaceuticals PLC
Bedford, OH

Quick Apply

Job Details

Full-time
$45,000 - $75,000 a year
1 day ago

Benefits

Paid parental leave
Paid holidays
Disability insurance
Health insurance
Dental insurance
401(k)
Tuition reimbursement
Paid time off
Parental leave
Vision insurance
Employee discount
Life insurance
Prescription drug insurance

Qualifications

Bachelor of Science
Data analysis skills
GMP
Bachelor's degree
Pharmaceutical company experience
Training & development
Manufacturing company experience

Full Job Description

Job Title: Batch Record Reviewer

Job Type: Full-time

Location: Bedford, Ohio

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

JOB PURPOSE:

The Specialist, QA Compliance will support the Quality Group by implementing and maintaining Quality Compliance policies/strategies in alignment with all regulatory authorities/guidance and Hikma Corporate plans and policies. The Specialist, QA Compliance will also evaluate any possible significant trends across the site and help drive continuous improvement efforts to adhere to regulatory requirements.

KEY ACCOUNTABILITIES:

Assist in implementing and overseeing systems relating to: CAPA, Change Control, Annual Product Review, GMP, Supplier Quality, Recalls, Field Alerts, Internal & External Auditing, Customer Complaints, 483 Gap Analysis, etc.

Assist with ensuring compliance with the FDA CFR, including cGMP and DEA regulations, as well as State Board of Pharmacy rules and regulations.
Monitor and communicate changes in regulations of all state and federal regulatory agencies.
Assist in collaborating on stability study protocols, Master Batch Records, and product specification requirements ensuring compliance with all company procedures and federal and state laws, rules, and regulations.

Primary Accountabilities:

NOTE: The primary accountabilities below describe the general content of and requirements of this position. This is not an exhaustive statement of duties.

Support inspection readiness program
Oversee customer complaints and adverse drug reaction program.
Participate in product trend analysis, including owning the Annual Product Review program.
Perform periodic gap analyses on 483 observations and new regulatory guidance’s.
Assist in writing, review and update of batch records, SOPs, and other cGMP documents.
Manage execution of internal and external audits to assess and maintain compliance with regulatory and customer requirements.
Assist the Quality Group in response to regulatory requests and inspection audits. Review, prepare, and/or approve all written responses to audits and inspections.
Oversee Supplier Quality program, including review and approval of Supplier Qualification & Performance documents (i.e., supplier audits, notifications, CAPAs, etc.). Initiate, review, and/or approve Quality (and Technical) Agreements.
Participate in the preparation and execution of dashboard metrics evaluating key performance indicators for all departments.
Participate / execute Internal Audits as per Annual schedule, compile report, review CAPA responses.
Participate in the administration of Site Projects.
Assist in the development and provision of GMP, Aseptic Behavior, and Quality Systems-related training to all applicable departments.
Provide technical support in the interactions with and applications to state and federal regulatory bodies.
Support for Documentation control activities (issuance of Batch Records, Logbooks, etc) as a backup.
Other duties, as assigned.

QUALIFICATIONS:

Bachelor of Science in Pharmacy, Chemistry, Microbiology, or other scientific disciplines.

EXPERIENCE:

Minimum:

1 – 3 years of pharmaceutical industry experience.

Preferred:

Experience in Quality Systems and Compliance.
Knowledge of Injectables manufacturing process / practices.
Knowledge of associated standards and operating procedures in relation to cGMP.

SKILLS:

The ability to change direction and focus to meet shifting organizational and business demands.
The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback, and recognition.
The ability to effectively manage self, demonstrate integrity, be productive under pressure, and achieve development goals.
The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity.
The ability to manage multiple resources and be accurate and current with data and information.
Ability to communicate technical information to non-technical personnel.
A broad perspective to organize objectives, both long-term and day-to-day activities.

What We Offer:

Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third parties in the event a candidate they refer is hired by Hikma.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Pay: $45,000.00 - $75,000.00 per year

Benefits:

Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

microbiology jobs in willoughby, oh

Batch Record Reviewer

Part-Time Laboratory Technologist (MLT)

Medical Technologist/MLT/Lab Technician - Clinical Microbiology

Consultant, Scientific and Laboratory Informatics

Lab Team Leader - Microbiology

Infection Preventionist-TriPoint

Infection Preventionist I

Histopathology Technologist (Lab Information Manager)

Medical Supply Technician (Sterile Processing)

GxP Lab Computing Analyst

Medical Technologist/MLT/Lab Technician IV - Clinical Microbiology

Research Assistant 3

Histotechnologist - Immunohistochemistry

Senior Director, Global Gas Technology

Senior Research Assistant 1

Histotechnician/Histotechnologist

Supervisory Histopathology Technologist

Research Technician II - Awoniyi Lab

Quality Assurance Manager - Market Garden Brewery

Management Consulting Delivery Specialist , Scientific and Laboratory Informatics

I want to receive the latest job alert for microbiology in willoughby, oh

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