Join Our Team and Shape the Future of OTC Pharmaceuticals
We are Hiring
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
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.
ANALYTICAL SCIENTIST is needed to perform the following duties:
- Develop, Qualify, and validate Analytical test methods.
- Read pharmaceutical literature and understand the properties of drug compounds and develop comprehensive test methods that are dependable and repeatable.
- Multiple tests are required to qualify and quantify a drug compound. Understanding various techniques and instruments is required.
- Perform experiments according to good laboratory practices and SOP execution.
- Always follow good laboratory practices in everyday activities like chemicals usage, documentation.
- Follow the established Standard Operating Procedures in testing.
- Conduct Assay, Content Uniformity, Related Compounds, and dissolution testing
- Test, review and approve the incoming raw materials, bulk products, and finished products as per the USP standards.
- Testing of raw materials immediately upon receipt, which will be used in R&D and commercial batches.
- ln- process and final testing of finished products before shipping it out to customers.
- Drug Stability studies
- Perform accelerated and long-term stability studies of the drug substances by placing them in appropriate stability chambers, pull out in timely manner for testing.
- Evaluate the stability samples at each time interval and prepare a stability data report which includes physical testing, chemical testing, and microbial testing.
- Prepare for or participate in quality assurance audits conducted by external or federal agencies.
- Perform tasks and document as mentioned in the facility SOP’s.
- Draft or update the SOP’s if needed.
- Daily calibration of the laboratory balance and other equipment.
- Work in a GMP and FDA regulated environment and maintenance of lab areas and equipment.
Bachelor’s Degree is required in Chemistry .
Quality CDMO is a pharmaceutical manufacturing company looking for a strong, self-motivated individual to join the operations team 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.
Quality Control Analyst is needed to perform the following duties:
- Perform Line Clearance and GMP monitoring activities for pharmaceutical manufacturing and packaging processes.
- Plan and Execute projects in support of client needs and internal projects including developing and validating analytical methods in support of product development
- Conduct OOS and OOT Investigations, perform troubleshooting and problem-solving
- Perform analytical method validation protocols and reports, write and maintain applicable analytical SOP’s
- Perform Quality assurance support of manufacturing, laboratory, and warehouse areas to ensure compliance with cGMP requirements and company procedures
- Write and Review and Approve Standard Operating Procedures (SOP’s) to ensure cGMP Compliance and Perform Periodic Review of any SOP’s associated with Quality
- Overseeing and supporting the release of final packaged products for shipping to/from the warehouse
- Review and Approve Cross functional SOP’s on behalf of Quality.
- chedule experiments and Prioritize assignments to meet project objectives and deadlines
- Maintain regulatory databases by conducting and reviewing the change controls, deviations, investigations and CAPA
- Coordinating different teams to foster the exchange of ideas and provide cross team learning opportunities.
Bachelor Degree is required in Pharmacy or Drug Regulatory Affairs or Pharmac
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.
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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