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CSI Specialty Group

QA Manager

Post Date:Feb 09, 2018Type:Full-Time
Start Date:2/9/2018Salary:$115,000.00
Location:US-TX-Houston Job Reference:
Skills:

 

EDUCATION AND/OR EXPERIENCE

·         Advanced knowledge and application of FDA regulations (cGMP, GLP, Data Integrity)

·         Demonstrated skills in taking initiative and self-motivation

·         Logical in thought and detail focused

·         Strong facilitation skills

·         Ability to lead cross-functional meetings

·         Demonstrated ability to bring consensus among diverse cross-functional teams

·         Drive results within established timelines

·         Excellent communication skills required

·         Written and verbal skills

·         Presentation, interpersonal communication skills

·         Must be detail oriented

·         Ability to work well under pressure in a fast paced working environment

·         Ability to perform quality work within deadlines and minimal supervision

·         Must possess strong keyboard skills entering alpha and numerical data

·         Working knowledge with Microsoft Office programs, especially Excel

·         Proficient reading, writing, grammar, and mathematics skills

·         Must be able to work from 5pm - 2am - Monday - friday

CERTIFICATIONS, LICENSES, AND REGISTRATIONS

·         CPHQ Certification, preferred

·         Green Belt/Black Belt certification, preferred

 

PHYSICAL DEMANDS AND WORK ENVIRONMENT

The physical demands and work environment are characteristic of those found in a typical laboratory environment. Potential exposure to chemicals used in the preparation of compounds (some chemicals are classified as toxic and special safety precautions must be taken when working with these chemicals). Some travel may be required. Reasonable accommodations may be made for individuals with disabilities to perform essential functions.



Job Description:

POSITION SUMMARY

The Quality Assurance Manager (QAM) is responsible for ensuring compliance of all aspects of the site cGMP operations in accordance with company policies, site procedures, government regulations, and safety requirements. The QAM is an independent reviewer and approver with respect to manufacturing, quality control, R&D, logistics, and other different functions at the site. Please know the shift will be from 5pm to 2AM Monday - Friday.

ESSENTIAL DUTIES AND RESPONSIBILITIES

·         Ensure compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Parts 211 and 212 requirements, by implementing an effective and efficient quality management system and maintaining a state of cGMP control at the site

·         Author, review, and approve cGMP documents, including various procedures, protocols, specifications, reports, records, and changes to these documents.

·         Implement an ongoing training program to qualify the site personnel following the SOPs to perform their functions at all times. Ensure the training covers any newly released procedures, revised procedures, and cGMP updates

·         Ensure aseptic operations are in compliance with internal procedures (gowning, cleaning/sanitation, sterility, environmental monitoring, etc.…), customer requirements, and FDA regulations. Assure completeness, accuracy, traceability, and compliance of the site utility and facility monitoring methods and records

·         Ensure that all equipment/instruments are appropriately maintained, calibrated/recalibrated, or validated/revalidated in a timely manner. Create and update a comprehensive tracking system. Review all logbooks for accurate record keeping

·         Improve incoming material acceptance program for different applications, including commercial manufacturing as appropriate. Ensure that raw materials, components, containers, closures, packaging, and labeling are inspected, qualified, and meet acceptance criteria before use

·         Review and approve final drug product labels, reagents, manufacturing batch records, associated EM data, QC analytical testing results, and Certification of Analysis for conformance to SOPs, specifications, regulations, and other applicable acceptance criteria to ensure compliance and product quality. Release or reject final drug products

·         Review, edit, and approve Change Control, Deviation, OOS investigation, and CAPA. Closely track and follow-up on these activities for timely closure. Ensure that scientifically sound investigations are conducted and root causes are identified. Initiate and Implement CAPA plans. Evaluate effectiveness of the CAPA plans through reporting and trending

·         Provide on-the-floor QA oversight of manufacturing, QC, and other cGMP activities. Identify non-compliance problems and propose solutions. Effectively interact with other functional personnel and resolve quality related issues on the spot whenever possible

·         Establish a self-audit program. Regularly conduct internal self-audit for quality management system effectiveness. Document the findings in a self-audit report. Initiate action plans to prevent cGMP non-compliance and product quality problems proactively. Ensure continuous and sustained improvements

·         Liaise with corporate QA audits, customer audits and regulatory agency audits. Perform readiness assessment and take corrective actions as needed prior to the audits. Summary and report auditing progresses daily. Prepare complete responses to the audit outcomes on time. Ensure corrective actions being implemented according to the committed timelines

·         Review customer/patient complaints to determine the possible root causes. Work with the customers to ensure their concerns are addressed, quality standards are met and issues are resolved promptly and effectively

·         Properly organize and securely archive the site cGMP documents. Keep all SOPs up to date and remove any obsoleted documents

·         Maintain knowledge of current regulations and quality policies. Attend quality related meetings and conference calls. Interface with corporate QA on quality related issues

·         Provide quality status updates as required by corporate QA

·         Perform other tasks as required

KNOWLEDGES SKILLS AND ABILITIES

·         Advanced knowledge and application of FDA regulations (cGMP, GLP, Data Integrity)

·         Demonstrated skills in taking initiative and self-motivation

·         Logical in thought and detail focused

·         Strong facilitation skills

·         Ability to lead cross-functional meetings

·         Demonstrated ability to bring consensus among diverse cross-functional teams

·         Drive results within established timelines

·         Excellent communication skills required

·         Written and verbal skills

·         Presentation, interpersonal communication skills

·         Must be detail oriented

·         Ability to work well under pressure in a fast paced working environment

·         Ability to perform quality work within deadlines and minimal supervision

·         Must possess strong keyboard skills entering alpha and numerical data

·         Working knowledge with Microsoft Office programs, especially Excel

·         Proficient reading, writing, grammar, and mathematics skills





Contact Information
CSI Specialty Group
Name: Jessica Oreste


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