Top 7 Quality assurance specialist Jobs in Conroe, Tx

Senior Quality Assurance Specialist
Cellipont Bioservices —The Woodlands, TX
- Weekends as needed
- Bachelor's degree
- Continuous improvement
- Mentoring
- Paid holidays
- Tuition reimbursement
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Quality Assurance Specialist
Amentum —Houston, TX
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Mid-level
- Employee stock purchase plan
- Paid holidays
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Asahi Kasei —The Woodlands, TX
- $80,000 - $100,000 a year
- Full-time
- Maintenance
- 8 years
- Bachelor's degree
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QC Senior Specialist, Raw Materials(W)
Cellipont Bioservices —The Woodlands, TX
- Full-time
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Paid holidays
- Tuition reimbursement
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Senior Quality Assurance Specialist

Cellipont Bioservices
The Woodlands, TX

Quick Apply

Job Details

Full-time

Benefits

Paid holidays
Tuition reimbursement
Paid time off
401(k) matching
Flexible schedule
Referral program

Qualifications

Incident investigation techniques for hazard identification
Investigations regulatory compliance
Quality records maintenance
Defect resolution root cause analysis
Laboratory document review
Document control experience within pharmaceutical industry
Preventive action implementation
Operations coordination
Internal compliance auditing
Production deviation management
Corrective and preventive actions (CAPA)
Internal investigations
Manufacturing standard operating procedures
Collaboration with product development teams
ICH guidelines
Bachelor's degree
Quality risk management
Continuous improvement
Video conferencing software
Pharmaceutical company experience
Team training
Technology transfer (scale-up process)
Quality assurance experience within pharmaceutical industry
Quality improvement
Compliance documentation
Client management
Mentoring
Microsoft Teams
Internal compliance assessments
Collaboration with manufacturing teams

Full Job Description

Bridging Innovation to Cure

"Developing and manufacturing your cell therapies from benchtop to bedside"

Summary

The Senior QA Specialist is a key member of the Quality Operations function. Within the Quality Operation function these individual responsibilities would include, batch release coordination, , review and approval of deviations, and ensuring compliance with applicable regulatory and industry standards for phase appropriate GMP manufacture of cell therapies. This position plays a key role demonstrating the values, culture and deliverables for the site.

The Role

Responsible for all aspects of batch disposition for designated client programs including real-time tracking of batch and documentation, cross-functional development of release timelines, communication of timelines and progress both internally and externally
Responsible for ensuring all documentation required for batch disposition is in the appropriate state for the level of disposition and providing the final disposition package to QA management for final disposition decision
Responsible for being the QA point of contact for assigned clients and interacting with clients on a frequent basis through a variety of methods including Microsoft Teams video meetings, email communication, and in-person meetings
Write, revise and approve GMP documentation as necessary including, but not limited to, SOPs, and specifications
Review and approve validations, qualifications, risk assessments, and testing methods.
Ensure that Quality requirements are met and appropriately documented for the product lifecycle according to procedures and regulatory requirements
Perform internal audits
Act as first responder for quality issues and actively pursue timely, compliant closure and documentation of all events and investigations and required immediate corrective actions. Participates in root cause analysis using methodologies, such as: fishbone, 5 whys, comparative analysis, etc.
Act as QA reviewer for investigations, deviations and CAPA; as designated by QA Management
Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.
Works cross-functionally with Project Management, Manufacturing, Facilities, MS&T, Development and Quality Control in meeting project deliverables in a compliant and efficient manner
Participate in site and corporate quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary
Actively participates in client audits
Provide training to more junior personnel within the team
Consistent vigilance for opportunities for improvement and championing those opportunities to closure
Perform additional duties as assigned

The Candidate

Bachelors Degree in a Life Science discipline
4-6 yrs.+ years' quality experience within pharmaceuticals, strong preference for biologics or advanced therapeutics
Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision
Hands-on experience with analytical method transfers/qualifications/validations
Hands-on experience with early, late, and commercial manufacturing process transfers/qualifications/validations
Knowledge of cGMP/ICH/FDA regulations
Excellent oral and written communication skills
Must be available to work occasional weekend or holiday support as needed
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Ability to work off-shift and extra hours as required which may include weekends and holidays as required

POSITION BENEFITS

Opportunities for career growth within an expanding team
Defined career path and annual performance reviewfeedback process
Cross-functional exposure to other areas within the organization
Robust benefit package designed for unique HealthWellness needs, including coverage for your furry family members
401K strong employer match
Tuition Reimbursement
Employee Referral Bonuses
Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
Gain experience in the cutting-edge cell therapy space

"At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!"

Notice to Agency and Search Firm Representatives

Cellipont Bioservices does not accept unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid writtensigned search agreement, will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral.

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quality assurance specialist jobs in conroe, tx

Senior Quality Assurance Specialist

Quality Assurance Specialist

QC Specialist

QC Senior Specialist, Raw Materials(W)

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