Support of GMP manufacturing processes, such as with release of incoming raw materials and issuance of batch records and test records. * Creation and maintenance of various document templates and ...
Support of GMP manufacturing processes, such as with release of incoming raw materials and issuance of batch records and test records. * Creation and maintenance of various document templates and ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
Quick apply
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
Lead Validation Engineer
Indianapolis, IN · On-site
Provide technical leadership for day-to-day development and GMP manufacturing support, including troubleshooting, risk assessments, and validation impact assessments. * Own and manage complex ...
Lead Validation Engineer
Indianapolis, IN · On-site
Provide technical leadership for day-to-day development and GMP manufacturing support, including troubleshooting, risk assessments, and validation impact assessments. * Own and manage complex ...
Lead Validation Engineer
Indianapolis, IN · On-site
Provide technical leadership for day-to-day development and GMP manufacturing support, including troubleshooting, risk assessments, and validation impact assessments. * Own and manage complex ...
Lead Validation Engineer
Indianapolis, IN · On-site
Provide technical leadership for day-to-day development and GMP manufacturing support, including troubleshooting, risk assessments, and validation impact assessments. * Own and manage complex ...
Senior MES Engineer
$97K - $134K/yr
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, GAMP5, and/or within highly regulated industries. The Senior MES Engineer will have expertise in SCADA ...
Senior MES Engineer
$97K - $134K/yr
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, GAMP5, and/or within highly regulated industries. The Senior MES Engineer will have expertise in SCADA ...
The first-ever facility of its kind, combining research and manufacturing in a single location, the ... Review and approve GMP documentation including procedures, deviations, technical reports, change ...
The first-ever facility of its kind, combining research and manufacturing in a single location, the ... Review and approve GMP documentation including procedures, deviations, technical reports, change ...
The first-ever facility of its kind, combining research and manufacturing in a single location, the ... Review and approve GMP documentation including procedures, deviations, technical reports, change ...
The first-ever facility of its kind, combining research and manufacturing in a single location, the ... Review and approve GMP documentation including procedures, deviations, technical reports, change ...
Review and approve GMP documentation including procedures, deviations, technical reports, change ... Experience in API manufacturing small and/or large molecules and/or high potent antibody drug ...
Review and approve GMP documentation including procedures, deviations, technical reports, change ... Experience in API manufacturing small and/or large molecules and/or high potent antibody drug ...
Senior MES Engineer
$94K - $129K/yr
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, GAMP5, and/or within highly regulated industries. The Senior MES Engineer will have expertise in SCADA ...
Senior MES Engineer
$94K - $129K/yr
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, GAMP5, and/or within highly regulated industries. The Senior MES Engineer will have expertise in SCADA ...
Senior MES Engineer
$94K - $129K/yr
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, GAMP5, and/or within highly regulated industries. The Senior MES Engineer will have expertise in SCADA ...
Quick apply
Senior MES Engineer
$94K - $129K/yr
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, GAMP5, and/or within highly regulated industries. The Senior MES Engineer will have expertise in SCADA ...
Senior MES Engineer
Fishers, IN · On-site
$97K - $134K/yr
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, GAMP5, and/or within highly regulated industries. The Senior MES Engineer will have expertise in SCADA ...
Senior MES Engineer
Fishers, IN · On-site
$97K - $134K/yr
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, GAMP5, and/or within highly regulated industries. The Senior MES Engineer will have expertise in SCADA ...
Experience with technology transfer from preclinical to clinical manufacturing environments. Working knowledge of GMP regulations (FDA, EMA, ICH guidelines) and NRC regulatory requirements.
Experience with technology transfer from preclinical to clinical manufacturing environments. Working knowledge of GMP regulations (FDA, EMA, ICH guidelines) and NRC regulatory requirements.
The Sr/Principal Scientist is responsible for the Upstream Process development, characterization, technology transfer and GMP manufacturing technical support. This individual will lead or contribute ...
Quick apply
The Sr/Principal Scientist is responsible for the Upstream Process development, characterization, technology transfer and GMP manufacturing technical support. This individual will lead or contribute ...
... GMP manufacturing operations. • Lead, design, plan, and execute scientific experiments supporting the development, scale-up, and automation of radiopharmaceutical drug product and API manufacturing ...
... GMP manufacturing operations. • Lead, design, plan, and execute scientific experiments supporting the development, scale-up, and automation of radiopharmaceutical drug product and API manufacturing ...
The first-ever facility of its kind, combining research and manufacturing in a single location, the ... Review and approve GMP documentation including procedures, deviations, technical reports, change ...
The first-ever facility of its kind, combining research and manufacturing in a single location, the ... Review and approve GMP documentation including procedures, deviations, technical reports, change ...
The Sr/Principal Scientist is responsible for the Upstream Process development, characterization, technology transfer and GMP manufacturing technical support. This individual will lead or contribute ...
The Sr/Principal Scientist is responsible for the Upstream Process development, characterization, technology transfer and GMP manufacturing technical support. This individual will lead or contribute ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
Gmp Manufacturing information
See Indiana salary details
$13.27 - $15.06
2% of jobs
$15.06 - $16.84
6% of jobs
$16.84 - $18.63
11% of jobs
$19.45 is the 25th percentile. Wages below this are outliers.
$18.63 - $20.42
13% of jobs
$20.42 - $22.21
12% of jobs
The median wage is $23.03 / hr.
$22.21 - $24
14% of jobs
$24 - $25.79
12% of jobs
$26.68 is the 75th percentile. Wages above this are outliers.
$25.79 - $27.57
12% of jobs
$27.57 - $29.36
9% of jobs
$29.36 - $31.15
6% of jobs
$31.15 - $32.94
4% of jobs
$13
$23
$32
How much do gmp manufacturing jobs pay per hour?
What is a GMP Manufacturing job?
A GMP Manufacturing job involves producing pharmaceutical, biotechnology, or medical device products while following Good Manufacturing Practices (GMP) regulations. Responsibilities typically include operating equipment, maintaining sterile environments, documenting processes, and ensuring product quality and compliance. These roles are essential for maintaining safety and regulatory standards in healthcare-related manufacturing industries.
What are the key skills and qualifications needed to thrive in the Gmp Manufacturing position, and why are they important?
To excel in GMP Manufacturing, you need a solid understanding of Good Manufacturing Practices, attention to detail, and experience in regulated production environments, often backed by a degree in life sciences or engineering. Familiarity with quality management systems, batch record documentation, and equipment such as bioreactors or chromatography columns is typically required, and certifications like GMP or Six Sigma can be beneficial. Strong teamwork, communication skills, and the ability to follow precise procedures are essential soft skills for this position. These competencies ensure safe, compliant, and efficient production of pharmaceuticals or biotechnology products within strict regulatory frameworks.
What are some common challenges faced in GMP Manufacturing roles?
Employees in GMP Manufacturing often encounter challenges such as maintaining meticulous documentation, adapting to changing regulatory requirements, and adhering to strict cleanliness and safety standards. The production process must be tightly controlled and deviations must be reported and resolved promptly, which requires a high level of diligence and accountability. Additionally, working collaboratively with quality assurance, engineering, and other cross-functional teams can add complexity to daily operations. Overcoming these challenges helps ensure product quality and regulatory compliance, while also providing valuable professional experience in one of the most highly regulated industries.

Full-time
Re-posted 21 days ago
Job description
Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs. At our US headquarters in Westfield, we will be next door to our key customers, delivering our products just in time, each day, every day. We are seeking a highly motivated and detail-oriented Quality Assurance Administrative Specialist to join our dynamic team. You will play a crucial role in ensuring the safe and efficient production of our products. This position is responsible for ensuring the efficient management of controlled documentation, quality records, training records, and administrative quality system activities. You will serve as a key coordinator for QA documentation and records management, compliance with current Good Manufacturing Practices (cGMP), FDA regulations (21 CFR Parts 210 and 211), and applicable EU GMP requirements. You will be part of a family and a team, dedicated to our mission to deliver on our covenant with our customers.
Responsibilities:
- Management of a document control process for a cGMP manufacturing site.
- Support the creation, formatting and approval of standard operating procedures, forms, and templates.
- Creation and implementation of hard-copy and electronic filing systems for GMP drug manufacturing, including maintaining critical quality documents on and off site.
- Support of GMP manufacturing processes, such as with release of incoming raw materials and issuance of batch records and test records.
- Creation and maintenance of various document templates and databases.
- Actively track and manage on-time record closure for critical records at the site.
- Support the ongoing development and improvement of the quality management system (QMS).
- Support the preparation and submission of regulatory filings, agency responses, and supplements to include FDA deficiency resolution, annual reporting and other correspondence between Isotopia and regulatory agencies (Nuclear Regulatory Agency, Food and Drug Administration, etc).
- Execution of other tasks as needed to support ongoing tasks and projects critical to the success of the site.
Requirements
Education and Skills:
- A minimum of an A.S. degree in the life sciences or business administration is required. B.S. degree is preferred.
- Extensive experience and confirmed high-level competence with MS Word, Excel, and PowerPoint is required.
- 3+ years working in a quality control or quality assurance position supporting GMP manufacturing is preferred.
- Experience working in pharmaceutical or other regulated environments preferred.
- Strong understanding of cGMP requirements is preferred.
- Detail-oriented mindset with excellent organizational and record-keeping skills.
- Effective communication and teamwork abilities, with a focus on collaborative problem-solving.
- Ability to work in a regulated and fast-paced environment while maintaining a high level of accuracy.
- Flexibility to work in shifts and handle time-sensitive processes.
- Strong commitment to safety, ethical conduct, and compliance with regulations.
Benefits
We offer a competitive salary, a comprehensive benefits package and advancement opportunity.
As an Equal Opportunity Employer, we are committed to a diverse workforce.