Columbus, OH Job Type: Full time Req ID: 10915 About Us: As a developer, manufacturer, and supplier ... Experience and Inspection interaction with FDA, EMA or other regulatory agencies required.
Columbus, OH Job Type: Full time Req ID: 10915 About Us: As a developer, manufacturer, and supplier ... Experience and Inspection interaction with FDA, EMA or other regulatory agencies required.
FT- Pharmacist in Charge
Newark, OH · On-site
$52.50 - $64/hr
We are hiring for a Full Time Pharmacist in Charge for our store in Newark, OH. We offer ... inspections. Provides pharmacological information by answering questions and requests of health ...
FT- Pharmacist in Charge
Newark, OH · On-site
$52.50 - $64/hr
We are hiring for a Full Time Pharmacist in Charge for our store in Newark, OH. We offer ... inspections. Provides pharmacological information by answering questions and requests of health ...
Quality Manager 503b cGMP Pharmacuetical
Albany, OH · On-site
$110K/yr
Albany, OH, Onsite Job Type: Full Time Schedule: Mon- Fri Compensation: The base pay range for this ... including inspections from FDA and state Boards of Pharmacy. * Create annual product reviews.
Quality Manager 503b cGMP Pharmacuetical
Albany, OH · On-site
$110K/yr
Albany, OH, Onsite Job Type: Full Time Schedule: Mon- Fri Compensation: The base pay range for this ... including inspections from FDA and state Boards of Pharmacy. * Create annual product reviews.
Kosher Chef
Beachwood, OH · On-site
Knowledge of kitchen sanitation, inspection processes and all FDA and Ohio Department of Health ... Full Time o Every other weekend as required o Day shift
New
Quick apply
Kosher Chef
Beachwood, OH · On-site
Knowledge of kitchen sanitation, inspection processes and all FDA and Ohio Department of Health ... Full Time o Every other weekend as required o Day shift
New
Quality Assurance Specialist
Norwalk, OH · On-site
$23 - $25/hr
... inspections, including AIB, HACCP, FDA, SQF, and customer audits. * Manage product holds and work ... IND3 Employment Type: FULL_TIME
Quality Assurance Specialist
Norwalk, OH · On-site
$23 - $25/hr
... inspections, including AIB, HACCP, FDA, SQF, and customer audits. * Manage product holds and work ... IND3 Employment Type: FULL_TIME
Fsqa Tech 4th Shift
$21 - $25/hr
We currently have 2 full-time open positions to fill on our "4th" shift which is Friday, Saturday ... inspections Collect and analyze product samples as required, as well as document information ...
Fsqa Tech 4th Shift
$21 - $25/hr
We currently have 2 full-time open positions to fill on our "4th" shift which is Friday, Saturday ... inspections Collect and analyze product samples as required, as well as document information ...
FSQA Tech 4th Shift
Delphos, OH · On-site
$21 - $25/hr
We currently have 2 full-time open positions to fill on our "4th" shift which is Friday, Saturday ... Responsible for pre-operational inspections * Collect and analyze product samples as required, as ...
FSQA Tech 4th Shift
Delphos, OH · On-site
$21 - $25/hr
We currently have 2 full-time open positions to fill on our "4th" shift which is Friday, Saturday ... Responsible for pre-operational inspections * Collect and analyze product samples as required, as ...
Quality Assurance Specialist - Night Shift
Columbus, OH · On-site
$23.29 - $25/hr
... inspections, including AIB, HACCP, FDA, SQF, and customer audits. * Manage product holds and work ... IND3 Employment Type: FULL_TIME
Quality Assurance Specialist - Night Shift
Columbus, OH · On-site
$23.29 - $25/hr
... inspections, including AIB, HACCP, FDA, SQF, and customer audits. * Manage product holds and work ... IND3 Employment Type: FULL_TIME
Quality Assurance Lead
Johnstown, OH · On-site
Food Safety Manager - OH Status: Full-time, Hourly Job Summary The Quality Assurance (QA) Lead ... to FDA, USDA, and SQF requirements. This position works directly with the Compliance Team ...
Quality Assurance Lead
Johnstown, OH · On-site
Food Safety Manager - OH Status: Full-time, Hourly Job Summary The Quality Assurance (QA) Lead ... to FDA, USDA, and SQF requirements. This position works directly with the Compliance Team ...
... Full-Time, Monday-Friday, 7:00 AM to 3:30 PM Position Summary The Food Safety and Quality Manager ... Ensure compliance with FDA, state, local, and company food safety requirements * Lead internal ...
... Full-Time, Monday-Friday, 7:00 AM to 3:30 PM Position Summary The Food Safety and Quality Manager ... Ensure compliance with FDA, state, local, and company food safety requirements * Lead internal ...
Senior Quality Systems Specialist
Mentor, OH · On-site
$73K - $101K/yr
This role manages document control transactions, site record retention, calibration and inspection ... FDA/ISO 13485) * Knowledge of standard quality analysis tools (Problem Solving/Root Cause Analysis)
Senior Quality Systems Specialist
Mentor, OH · On-site
$73K - $101K/yr
This role manages document control transactions, site record retention, calibration and inspection ... FDA/ISO 13485) * Knowledge of standard quality analysis tools (Problem Solving/Root Cause Analysis)
... Full-Time, Monday-Friday, 7:00 AM to 3:30 PM Position Summary The Food Safety and Quality Manager ... Ensure compliance with FDA, state, local, and company food safety requirements * Lead internal ...
... Full-Time, Monday-Friday, 7:00 AM to 3:30 PM Position Summary The Food Safety and Quality Manager ... Ensure compliance with FDA, state, local, and company food safety requirements * Lead internal ...
Machine Operator - Akron
Akron, OH · On-site
$18 - $20/hr
... inspections and basic troubleshootingIdentify quality, food safety, or equipment concerns and ... Full-time, stable employment with a growing companyCompetitive pay based on experienceOpportunities ...
Quick apply
Machine Operator - Akron
Akron, OH · On-site
$18 - $20/hr
... inspections and basic troubleshootingIdentify quality, food safety, or equipment concerns and ... Full-time, stable employment with a growing companyCompetitive pay based on experienceOpportunities ...
SANITATION SUPERVISOR
Fairfield, OH · On-site
$65K/yr
Conduct self-inspections and internal audits to validate sanitation effectiveness (visual ... Ensure compliance with SQF, HACCP, GMPs, and FDA regulations. * Work collaboratively with Quality ...
Quick apply
SANITATION SUPERVISOR
Fairfield, OH · On-site
$65K/yr
Conduct self-inspections and internal audits to validate sanitation effectiveness (visual ... Ensure compliance with SQF, HACCP, GMPs, and FDA regulations. * Work collaboratively with Quality ...
Machine Operator - Akron
$16.25 - $19.25/hr
Perform routine equipment inspections and basic troubleshooting * Identify quality, food safety, or ... Follow all FDA, GMP, safety, and company procedures * Support other production operations as needed ...
Machine Operator - Akron
$16.25 - $19.25/hr
Perform routine equipment inspections and basic troubleshooting * Identify quality, food safety, or ... Follow all FDA, GMP, safety, and company procedures * Support other production operations as needed ...
Machine Operator - Akron
Akron, OH · On-site
$18 - $20/hr
Perform routine equipment inspections and basic troubleshooting * Identify quality, food safety, or ... Follow all FDA, GMP, safety, and company procedures * Support other production operations as needed ...
Machine Operator - Akron
Akron, OH · On-site
$18 - $20/hr
Perform routine equipment inspections and basic troubleshooting * Identify quality, food safety, or ... Follow all FDA, GMP, safety, and company procedures * Support other production operations as needed ...
Food Manufacturing Production Associate 1st Shift
Columbus, OH · On-site
$18/hr
Comply with all USDA, FDA, ODA regulations * Understand and perform all Standard Operating ... Inspect product for quality defects along the production line. * Place finished goods into cases or ...
Food Manufacturing Production Associate 1st Shift
Columbus, OH · On-site
$18/hr
Comply with all USDA, FDA, ODA regulations * Understand and perform all Standard Operating ... Inspect product for quality defects along the production line. * Place finished goods into cases or ...
Food Manufacturing Production Associate 3rd Shift
Columbus, OH · On-site
$18/hr
Comply with all USDA, FDA, ODA regulations * Understand and perform all Standard Operating ... Inspect product for quality defects along the production line. * Place finished goods into cases or ...
Food Manufacturing Production Associate 3rd Shift
Columbus, OH · On-site
$18/hr
Comply with all USDA, FDA, ODA regulations * Understand and perform all Standard Operating ... Inspect product for quality defects along the production line. * Place finished goods into cases or ...
2nd Shift Quality Assurance Tech Level 1
Louisville, OH · On-site
$19.50/hr
F/T Benefits: Medical / Dental / Vision / Life Insurance / Disability / 401(k) Position Summary ... Conduct Sanitation Pre-Op inspections * Support production personnel's quality needs on the ...
2nd Shift Quality Assurance Tech Level 1
Louisville, OH · On-site
$19.50/hr
F/T Benefits: Medical / Dental / Vision / Life Insurance / Disability / 401(k) Position Summary ... Conduct Sanitation Pre-Op inspections * Support production personnel's quality needs on the ...
Flock Specialist
Croton, OH · On-site
$21/hr
Production Manager Job Type: Full-time Compensation: $21.00/ HR Job Summary The Flock Specialist I ... to FDA, USDA, SQF, and OSHA standards. Work is subject to general supervision through inspections ...
New
Flock Specialist
Croton, OH · On-site
$21/hr
Production Manager Job Type: Full-time Compensation: $21.00/ HR Job Summary The Flock Specialist I ... to FDA, USDA, SQF, and OSHA standards. Work is subject to general supervision through inspections ...
New
Full Time Fda Inspector information
What is the difference between Full Time Fda Inspector vs Part Time Fda Inspector?
| Aspect | Full Time Fda Inspector | Part Time Fda Inspector |
|---|---|---|
| Credentials | Typically requires a bachelor's degree in life sciences or related field, plus FDA inspector certification | Same as full-time, but may have more flexible certification requirements |
| Work Environment | Full-time, on-site inspections at manufacturing facilities, laboratories, and warehouses | Part-time, often involves scheduled inspections or follow-ups |
| Employer & Industry Usage | FDA, government agencies, regulated industries | FDA, contractors, or consulting firms |
Full Time Fda Inspectors work primarily on-site, conducting regular inspections and ensuring compliance with FDA regulations. Part Time Fda Inspectors perform inspections on a flexible schedule, often supplementing full-time staff. Both roles require similar credentials but differ mainly in hours and scope of work.
What are the key skills and qualifications needed to thrive as a full time FDA inspector?
What does a full time FDA inspector do?
What are some common challenges faced by full time FDA inspectors during facility inspections?

Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 23 days ago
Hikma Pharmaceuticals rating
8.0
Based on 30 frontline employees who took The Breakroom Quiz
43rd of 86 rated pharmaceutical
Job description
Location: Columbus, OH
Job Type: Full time
Req ID: 10915
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 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 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Engineer, Cleaning Validation to join our team.
In this role, you will be responsible for developing, maintaining, and approving the cleaning validation requirements ensuring compliance to the applicable business and regulatory standards. Develop and maintains site cleaning and cleaning validation processes from product development through product lifecycle. Review and approve the cleaning procedures and support the process to educate those performing the cleaning on the expectations and intent of cleaning, inspection, and cleaning verification sampling. Defines testing strategies and document the performance and compliance of the cleaning validation program. Interfaces with regulatory inspections, investigations and site projects.
Key Responsibilities:
- Develops and approves validation deliverables, which comply with regulatory guidelines and business requirements. Represent CV during regulatory inspections.
- Conduct periodic reviews of the compliance of cleaning processes to the validated state and to ensure the effectiveness of the cleaning validation program.
- Revise and approve procedures for cleaning processes utilized in operations including cleaning, inspection, and cleaning verification work instructions.
- Support the implementation of the optimization and improvements in a consistency and effectiveness ways of cleaning processes.
- Support employee training to ensure compliance to procedure and process effectiveness.
- Establishes and/or participates in the creation of policies, procedures, guidelines, and templates in the area of validation. Provide leadership and direction to manage the testing approach and cleaning swab sample locations on new equipment and/or for new products, with the appropriate direction on the alignment with the philosophy defined by the Cleaning Validation engineering team.
- Lead, define and manage the mentoring and training of Cleaning Validation colleagues on policies and procedures including the cleaning validation process.
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
- Bachelor's degree in engineering or related scientific discipline.
- Minimum of eight (8) years of pharmaceutical industry experience in quality, production, engineering or a laboratory setting.
- 5+ years specific cleaning validation experience in a pharmaceutical environment. Three years of that experience by a combination of equipment qualification, process validation, or cleaning validation is acceptable.
- Experience with the authoring and execution of Quality documentation including validation documentation, technical protocols and/or technical reports. Strong knowledge of FDA Current Good Manufacturing Practices (cGMP), ISPE's Risk-Based Manufacture of Pharmaceutical Products, and ICH Q9 Quality Risk Management. Experience and Inspection interaction with FDA, EMA or other regulatory agencies required.
- Ability to define a problem; collect, statistically analyze, and interpret data; contribute to development of corrective and preventative actions (CAPA) and implementation plans.
- Demonstrated knowledge of project management skills and techniques, ability to prepare time lines and schedules to ensure projects are executed on time. Excellent organization skills with demonstrated ability to manage multiple projects and deadlines simultaneously. Self-directed individual.
- Demonstrated skills in multitasking in an environment of high volume projects. Proven ability to shift thought processes quickly and accurately from one project to another.
- Demonstrated ability to apply critical thinking skills to identify problems. Experience is preferred to use the statistical analysis of data and trends to recognize symptoms, causes, and alternate solutions and makes timely sound decisions even under risk and uncertainty.
- Demonstrated ability for independent work that requires multi-tasking and a high level of attention to detail.
- Demonstrated ability to facilitate and/or be an active participant on teams.
- Demonstrated proficiency in interpersonal communications, both written (technical writing required) and verbal.
- Demonstrated successful communication/collaborative skills, influencing skills, and negotiation skills to manage conflicting and/or multiple demands, opinions, and expectations including ability to facilitate meetings as well as present to various levels within an organization.
- Demonstrate the ability to influence/persuade individuals to gain acceptance of an idea or plan is preferred.
- Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint). Knowledge of application software such as Change control system, SAP, Document Management system or Laboratory information system required.
Preferred Qualifications:
- 3+ years related experience in project or people management role preferably in a regulated environment.
- Quality experience in the pharmaceutical industry.
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 4% 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.
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About Hikma Pharmaceuticals
Sourced by ZipRecruiter
Industry
Pharmaceutical product wholesalers
Company size
5,001 - 10,000 Employees
Headquarters location
London, GL, GB