Career

Quality CDMO is a pharmaceutical contract development and manufacturing company looking for a strong, self-motivated individual who can support our growing team.

The ideal candidate will have experience in Quality System Development with a solid knowledge of relevant regulatory agency guidance including ICH, FDA and 21CFR.

Primary Responsibilities

• Conduct Quality audits for development and commercial products.
• Author and review procedures, specifications, quality reports, and other quality documents, customized to different client business processes and requirements.
• Assist all departments in the generation of quality system documentation, such as SOPs, deviation/investigation reports, equipment/system qualification protocols and reports, and change controls.
• Assist in document control activities (training records entries, logbook issuances, logbook archival etc.)
• Quality release of raw materials and finished products.
• Review of documentation supporting batch, warehouse, metrology, engineering, and validation activities to ensure they are complete and in compliance with company policies and procedures, and cGMP requirements.
• Perform quality assurance support of manufacturing, laboratory, and warehouse areas to ensure compliance with cGMP requirements and company procedures.
• Interface with cross-functional departments to resolve quality issues.
• Complies with all company policies and standards.
• Performs other functions as required or assigned.
• Ensure adherence to GMP good documentation practices.
• Support logistics and oversight of routine and investigational samples with our third-party Microbiology laboratories.
• Perform line clearance and GMP monitoring activities for pharmaceutical manufacturing and packaging processes.
• Review, approve and reject raw materials, packaging components and critical consumables for commercial manufacturing.
• Perform batch record review and approval according to company procedures and ensure compliance with GMP standards.
• Deviation review, evaluation and closure according to company procedures and ensuring compliance to GMP standards.
• QA rep for root cause analysis activities.
• Perform laboratory record /document review and approval according to company procedures and ensure compliance to GMP standards.
• Change Control/SOP author and review.
• Perform internal audits.

Basic Qualifications:

• Minimum bachelor’s degree in science or a technical discipline; advanced degree in Chemistry, Biology, or equivalent preferred.
• At least 3-5 years of work experience in Quality Assurance functions (i.e. Inspection, Auditing, Laboratory).
• Strong GMP knowledge and experience of current requirements of FDA regulations.
• Excellent verbal and written communication skills in English
• Demonstrate an ability to work as part of a team and possess an excellent work ethic.

Quality CDMO is a local, minority-owned business and an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

This position is in Fort Worth, TX

Job Type: Full-time

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We are seeking a Manufacturing Operator to join our team!
The operator must follow detailed batch instructions which includes precisely weighing and adding raw materials as part of making blending batches.
Will also perform packaging as needed
Responsible for training on all relevant SOPs and always maintain compliance with related SOPs and current Good Manufacturing Practices (cGMP) in the manufacturing process.
Perform duties through the proper, safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
Flexible to work extended hours, to achieve manufacturing schedule when needed.
Additionally, there is lifting required and is a essential part of this job and which includes but not limited to lifting and dumping of raw materials into blend kettles and transfer of materials.
Must accurately and legibly fill out all forms and batch records.
Requirements
Minimum of 5 years manufacturing experience.
Clear and comprehensive communication in English (written/verbal) required.
Basic mathematic and numeracy skills required.
Ability to work in a Team environment.
Committed to safety & organizational goals.
Self-motivated able to work with minimal supervision.
Available for on-call duty.
Ability to lift up to 50 lbs, climb ladders and stairs, and stand for continuous periods of time with or without reasonable accommodation.
Ability to work in a hot, humid, noisy and high volume machine production area.
Ability and willingness to work safely and wear PPE as required.

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Job description
MUST HAVE PRIOR PHARMACEUTICAL OPERATION EXPERIENCE

We are seeking a Manufacturing Operator to join our team!

The operator must follow detailed batch instructions which includes precisely weighing and adding raw materials as part of making blending batches.
Will also perform packaging as needed
Responsible for training on all relevant SOPs and always maintain compliance with related SOPs and current Good Manufacturing Practices (cGMP) in the manufacturing process.
Perform duties through the proper, safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
Flexible to work extended hours, to achieve manufacturing schedule when needed.
Additionally, there is lifting required and is a essential part of this job and which includes but not limited to lifting and dumping of raw materials into blend kettles and transfer of materials.
Must accurately and legibly fill out all forms and batch records.
Requirements

Minimum of 5 years manufacturing experience.
Clear and comprehensive communication in English (written/verbal) required.
Basic mathematic and numeracy skills required.
Ability to work in a Team environment.
Committed to safety & organizational goals.
Self-motivated able to work with minimal supervision.
Available for on-call duty.
Ability to lift up to 50 lbs, climb ladders and stairs, and stand for continuous periods of time with or without reasonable accommodation.
Ability to work in a hot, humid, noisy and high volume machine production area.
Ability and willingness to work safely and wear PPE as required.

Apply Now

Quality CDMO is a pharmaceutical contract development and manufacturing company looking for a strong, self-motivated individual who can support our growing team.

Primary responsibilities

Develop, qualify, and validate analytical test methods for drug products and excipients using a variety of technologies including HPLC, GC, FT IR, Karl Fischer, UV-Vis, and other wet laboratory procedures.
Conduct Assay, Content Uniformity, Related Compounds, and Dissolution routine testing
for internal projects and client.
Operation of environmental monitoring system.
Plan and execute projects in support of client needs and internal projects including developing and validating analytical methods in support of pharmaceutical product development, degradation studies, Performance qualification of instrumentation. Generate analytical method validation protocols and reports. Write and maintain applicable analytical SOPs.
Perform experiments according to established Standard Operating Practices (SOP}, Good
Laboratory Practices (GLP}, as well as any applicable federal regulations or industry standards.
Draft standard operating procedures and summary reports.
Develop stability study design and carry out stability studies using test methodology.
Work in a GMP and FDA regulated environment.
Conduct OOS investigations as necessary. Perform troubleshooting and problem-solving activities.
Schedule experiments and prioritize assignments to meet project objectives and
dealines.
Maintain R&D equipment’s and chemicals in a safe manner.
Quality CDMO is a local, minority-owned business and an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

This position is in Fort Worth, TX

Job Type: Full-time

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Develop, evaluate, and improve manufacturing processes for efficiency, safety, and quality. Design equipment layouts and process flow diagrams to meet GMP and FDA standards. Optimize process parameters to maximize yield and minimize waste. Lead technology transfer activities from R&D or clients to commercial production.

Ensure documentation (batch records, protocols, SOPs) is in place for new products. Develop and execute process validation protocols (IQ/OQ/PQ). Support continued process verification (CPV) programs in compliance with FDA/ICH guidelines.

Ensure all processes comply with cGMP, DEA regulations for controlled substances, and other regulatory requirements. Maintain and update process documentation (e.g., SOPs, change controls, deviation investigations). Investigate and resolve process-related deviations, complaints, or non-conformances. Implement corrective and preventive actions (CAPA) to address root causes.

Work closely with QA, QC, R&D, maintenance, and regulatory teams. Provide technical support during audits or regulatory inspections (FDA, DEA, etc.). Oversee daily manufacturing operations across OTC, controlled substances, and other pharmaceutical lines. Ensure production targets are met within timelines and quality parameters.

Ensure site-wide compliance with FDA, DEA, cGMP, and other applicable regulations in the pharmaceutical industry. Oversee documentation practices, audits, and inspections related to operations. Provide training and support to manufacturing personnel on new processes, equipment, and technologies.

Coordinate with planning, procurement, and logistics to ensure raw materials and components are available. Monitor inventory levels and control waste.

Ensure manufacturing equipment and facilities are maintained, qualified, and calibrated. Coordinate preventive maintenance schedules and facility upgrades.

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