Quality Assurance Specialist (Cell Therapy)

Cellipont Bioservices; Silver Spring (MD); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

401K match

Tuition Reimbursement

Flexible work schedules

Job summary

Cellipont Bioservices is seeking a Quality Assurance Specialist to provide real-time QA support for GMP manufacturing of cell therapies. The role includes on-the-floor monitoring, room release, and reviewing critical documentation to ensure compliance.

The candidate will perform audits, participate in root-cause analyses, and assist with lot disposition while maintaining and improving SOPs and QA systems. A Bachelor's degree and GMP experience are preferred.

Qualifications

• Bachelor's degree preferred with 2+ years of GMP industry experience.
• Knowledge of cell therapy manufacturing processes is a plus.
• Proven analytical and problem-solving abilities.
• Ability to learn new processes and work both in teams and independently.

Responsibilities

• Perform QA on-the-floor activities during manufacturing, including room release and in-process review.
• Audit manufacturing and support areas for adherence to procedures and quality standards.
• Review, disposition and documentation of batch records for accuracy and compliance.
• Act as first responder for quality issues and document investigations and corrective actions.
• Participate in root cause analysis using standard methodologies.
• Support lot disposition and evaluation of cell therapies.
• Write and revise GMP documentation and administer SOPs.
• Engage in site and corporate quality improvement initiatives.

Skills

Analytical skills

Troubleshooting

Decision making

Team collaboration

On-the-floor QA

Documentation review

Education

Bachelor's Degree

Tools

Microsoft Access

Excel

Job description

Job Description

Job Description

Job Summary

Cellipont Bioservices is growing, and we are looking for a

Quality Assurance Specialist

who believes in the potential of bridging client's discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.The

Quality Assurance Specialist

will be responsible for monitoring systems and procedures to ensure compliance where applicable. The Quality Assurance Specialist is responsible for providing Quality Assurance support real-time for GMP Manufacturing of Cell Therapies. This individual will be responsible for providing QA on the Floor during manufacturing including observing critical processes, review executed GMP documentation, and supporting other QA functions as needed.

The Role

• Performs QA On-the-Floor activities supporting client projects, including roomrelease, auditing critical processes, reviewing documentation in real time, andresolving issues that occur during manufacturing.
• Perform audits of manufacturing and support areas, including in-process batchrecord review for adherence to internal procedures and industry best practices.
• Review and dispositions executed batch records and supporting documentation forcompleteness, accuracy and compliance.
• Act as first responder for on the floor quality issues in a timely manner,documentation of all events/investigations and required immediate correctiveactions.
• Participates in root cause analysis using methodologies, such as: fishbone, 5 whys,comparative analysis, etc.
• Support the evaluation and lot disposition of cell therapies
• Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing documentation in real time, and resolvingissues that occur during manufacturing. Also perform Acceptable Quality Limit (AQL)visual inspection of drug product
• Write and revise GMP documentation as necessary
• Accountable for administration and tracking of Standard Operating Procedures(SOPs)
• Participate in site and corporate quality and process improvement initiatives.
• Guides personnel indirectly and directly involved in GMP operations pertaining tocGMP compliance, internal procedures, regulatory requirements and industry bestpractices.

The Candidate

• Bachelor's Degree preferred with a minimum of 2+ years of direct GMP industryexperience
• Knowledgeable and/or exposure manufacturing processes related to cell therapy
• Creative individual with excellent analytical, trouble shooting, and decision-makingskills
• Ability to quickly learn new and novel manufacturing processes supporting newclients
• Able to work in a team setting and independently under minimum supervision
• Familiarity with electronic systems, including developing and producing reports usingMicrosoft Access and Excel
• Intermediate knowledge of Microsoft Office and database management skills,organization, and record keeping skills required.
• Clear problem-solving and decision-making skills
• Ability to function well in a changing environment and work overtime occasionally and on weekends as needed

Position Benefits

• Opportunities for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross-functional exposure to other areas of within the organization
• Robust benefit package designed for unique Health & Wellness 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 is not accepting 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 written & signed 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. Thank you.