What are the responsibilities and job description for the Quality Control Planner position at Cellipont Bioservices?
Bridging Innovation to Cure
"Developing and manufacturing your cell therapies from benchtop to bedside."
Job Summary
Cellipont Bioservices is growing, and we are looking for a Quality Control Planner, who believes in the potential of bridging clients discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.
The QC Planner works in a fast-paced environment providing operational support to the quality control department of a CMO for the manufacturing of cell therapy drug substance, sterile finished drug product, and fill/finish operations. The QC Planner will be responsible for planning, coordinating, and scheduling quality control activities across various projects or operations to ensure adherence to quality standards and timelines as well as work on identification and implementation of process improvements within QC. This role requires close coordination with Manufacturing, Quality Assurance and Supply Chain to balance operational constraints and resource availability.
The Role
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 as a result of an unsolicited agency or search firm referral. Thank you.
"Developing and manufacturing your cell therapies from benchtop to bedside."
Job Summary
Cellipont Bioservices is growing, and we are looking for a Quality Control Planner, who believes in the potential of bridging clients discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.
The QC Planner works in a fast-paced environment providing operational support to the quality control department of a CMO for the manufacturing of cell therapy drug substance, sterile finished drug product, and fill/finish operations. The QC Planner will be responsible for planning, coordinating, and scheduling quality control activities across various projects or operations to ensure adherence to quality standards and timelines as well as work on identification and implementation of process improvements within QC. This role requires close coordination with Manufacturing, Quality Assurance and Supply Chain to balance operational constraints and resource availability.
The Role
- Create and maintain testing schedules for all CPB manufactured products and stability programs, considering priorities and deadlines.
- Ensure that testing, data review and reporting are tracked and completed on time.
- Monitor the laboratory capacity to handle testing volume and allocate resources accordingly.
- Oversee the tracking of samples throughout the QC process to ensure proper chain of custody.
- Track testing completion for delivery of CoAs on time for batch disposition.
- Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
- Monitor and report on the progress of QC schedules and performance metrics. Work in collaboration with Manufacturing in aligning testing to production schedule.
- Support the identification and implementation of process improvements within the quality control process, including lean lab initiatives.
- Manage material flow to ensure inventory is maintained to the optimum level to support testing deliverables.
- Assist in managing and tracking the resolution of any quality-related issues.
- Provide regular updates and reports to management regarding quality control activities, including potential delays or issues.
- Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
- Communicate effectively with cross-functional peers, department management, and other partners as needed.
- Bachelors Degree in a Life Sciences preferred with 4 years of relevant industry experience
- Proven experience in planning and scheduling within a quality control or manufacturing environment.
- Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision.
- Familiarity with QC standards, procedures, and industry regulations.
- Strong organizational skills with the ability to manage multiple tasks and meet deadlines.
- Excellent communication skills, both written and verbal.
- Ability to work collaboratively in a team-oriented environment.
- Strong analytical and problem-solving skills.
- Knowledge of quality control principles, testing methods, and regulatory standards.
- Opportunities for career growth within an expanding team
- Defined career path and annual performance review & feedback process
- Cross-functional exposure to other areas 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
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 as a result of an unsolicited agency or search firm referral. Thank you.
