QA Associate Manager
Company Name:
NeoStem/PCT
Quality Assurance Associate Manager (IMMEDIATE OPENING!!!)
We are seeking highly motivated and experienced QA Associate Manager who is interested in joining our fast-paced, dynamic environment.
This position requires that the ideal candidate supervises all aspects of Quality Assurance activity related to final product releases as well as assists the Director of Quality Assurance with department needs. The successful candidate must be able to work collaboratively with other team members across sites and projects. This position is based in Allendale, NJ
Responsibilities:
Develop and supervise QA Associate personnel.
Ensure the safe release of cellular products.
Ensure and promote compliance with applicable cGMP regulations and company and client SOPs.
Responsible for the timely closure of Batch Records, and deviation reports.
Review QC logs for QA review responsibilities.
Responsible for the completion of all client requirements related to cellular product and/or material releases.
Maintain good client relationship.
Oversee material disposition via deviation reporting system or client based system.
Prioritize, schedule and manage multiple projects and resources simultaneously.
Supervise change control activities, both facility and client specific.
Evaluate and investigate customer complaints and deviations; initiate and coordinate corrective and preventive actions.
Maintain all aspects of the deviation reporting system.
Maintain the environmental monitoring system and conduct trend analysis as required.
Provide training to personnel as required.
Maintain the document control system and related activities.
Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
Develop, revise and implement Standard Operating Procedures as related to Quality Assurance activities.
Complete projects and special tasks as assigned by supervisor.
Performs additional duties as assigned.
Occasional travel may be required
Education and
Experience:
Bachelor's degree in biological sciences or equivalent required
Minimum 5 years related experience in the pharmaceutical or biologics industry
Minimum 5 years QA/QC supervisory experience is required
Must have a strong understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)
Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc.
Sound knowledge of aseptic processing and supporting technologies
At least 3 years of experience with writing, reviewing and following Standard Operating Procedures
Must have the ability to handle multiple priorities, maintain confidentiality and interface with individuals from various departments and various companies at various levels.
MUST be flexible and will be expected to contribute to an exciting, productive and rigorous working environment
Ability to work in a fast-paced environment in results oriented fashion.
Must be very detailed oriented
Strong team-oriented interpersonal skills are essential
Excellent analytical, organizational and technical troubleshooting skills are a plus
Excellent verbal and written communication skills
About Us
PCT, a Caladrius company is among the first of a new breed of immunotherapy companies with proven expertise and unique experience in cell process optimization, development, and manufacturing. Caladrius is a cell therapy leader with late-stage clinical programs based on a proprietary platform technology for immuno-oncology, as well as additional platform technologies for ischemic repair and immunomodulation, and capabilities that support other cell therapy developers. This integrated approach supports the industry in bringing significant life-improving medical treatments to market.
We challenge our employees to become leaders in the emerging field of cellular therapy. It takes a team of experts to help us lead the paradigm shift in medicine-- a shift away from just treating symptoms and towards finding cures for chronic disease and illness.
Connect with us on LinkedIn at http://www.linkedin.com/in/pctcelltherapy
Follow us on Twitter @PCTcelltherapy
If you are interested in this exciting opportunity, please send a copy of your CV or Resume directly toEstimated Salary: $20 to $28 per hour based on qualifications.
NeoStem/PCT
Quality Assurance Associate Manager (IMMEDIATE OPENING!!!)
We are seeking highly motivated and experienced QA Associate Manager who is interested in joining our fast-paced, dynamic environment.
This position requires that the ideal candidate supervises all aspects of Quality Assurance activity related to final product releases as well as assists the Director of Quality Assurance with department needs. The successful candidate must be able to work collaboratively with other team members across sites and projects. This position is based in Allendale, NJ
Responsibilities:
Develop and supervise QA Associate personnel.
Ensure the safe release of cellular products.
Ensure and promote compliance with applicable cGMP regulations and company and client SOPs.
Responsible for the timely closure of Batch Records, and deviation reports.
Review QC logs for QA review responsibilities.
Responsible for the completion of all client requirements related to cellular product and/or material releases.
Maintain good client relationship.
Oversee material disposition via deviation reporting system or client based system.
Prioritize, schedule and manage multiple projects and resources simultaneously.
Supervise change control activities, both facility and client specific.
Evaluate and investigate customer complaints and deviations; initiate and coordinate corrective and preventive actions.
Maintain all aspects of the deviation reporting system.
Maintain the environmental monitoring system and conduct trend analysis as required.
Provide training to personnel as required.
Maintain the document control system and related activities.
Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
Develop, revise and implement Standard Operating Procedures as related to Quality Assurance activities.
Complete projects and special tasks as assigned by supervisor.
Performs additional duties as assigned.
Occasional travel may be required
Education and
Experience:
Bachelor's degree in biological sciences or equivalent required
Minimum 5 years related experience in the pharmaceutical or biologics industry
Minimum 5 years QA/QC supervisory experience is required
Must have a strong understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)
Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc.
Sound knowledge of aseptic processing and supporting technologies
At least 3 years of experience with writing, reviewing and following Standard Operating Procedures
Must have the ability to handle multiple priorities, maintain confidentiality and interface with individuals from various departments and various companies at various levels.
MUST be flexible and will be expected to contribute to an exciting, productive and rigorous working environment
Ability to work in a fast-paced environment in results oriented fashion.
Must be very detailed oriented
Strong team-oriented interpersonal skills are essential
Excellent analytical, organizational and technical troubleshooting skills are a plus
Excellent verbal and written communication skills
About Us
PCT, a Caladrius company is among the first of a new breed of immunotherapy companies with proven expertise and unique experience in cell process optimization, development, and manufacturing. Caladrius is a cell therapy leader with late-stage clinical programs based on a proprietary platform technology for immuno-oncology, as well as additional platform technologies for ischemic repair and immunomodulation, and capabilities that support other cell therapy developers. This integrated approach supports the industry in bringing significant life-improving medical treatments to market.
We challenge our employees to become leaders in the emerging field of cellular therapy. It takes a team of experts to help us lead the paradigm shift in medicine-- a shift away from just treating symptoms and towards finding cures for chronic disease and illness.
Connect with us on LinkedIn at http://www.linkedin.com/in/pctcelltherapy
Follow us on Twitter @PCTcelltherapy
If you are interested in this exciting opportunity, please send a copy of your CV or Resume directly toEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
