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Quality Assurance Manager

QA Manager will act as primary site representative for quality systems and ensure that all QA functions are compliant with GMP regulations and consistent with company policies and procedures in addition to conducting audits that insure continuous control over materials, facilities and products throughout the production cycle. This position reports directly to the Director of Quality.

Main responsibilities:

- Ability to manage and prioritize multiple projects for multiple direct reports,

- Maintaining all quality documentation and document tracking systems,

- Reviewing/approving GMP protocols and reports including those in support of lot-release programs, stability, qualification, and ICH validation activities,

- Investigating, documenting, and tracking GMP deviations, change control, risk management, CAPAs, etc.,

- Advancing, evolving, and improving all quality systems,

- Batch record review and designee approval,

- Act as a high-level technical resource for interpretation of policy, review and approval of
technical documents, and decision making for the quality unit as well as the site Quality,

- Oversee activities involved in the review and release of raw material and finished product with a focus on compliance to company policies and regulatory standards,

- Provides strategy and leadership during regulatory inspections and external audits, being part of the regulatory inspection team,

- Approval of Document Change Controls and Deviation Reports,

- Review and approve Validation Protocols and Reports,

- Conduct GMP training for staff and insures training is current with all required cGMP regulations

- Coordination with various departments for setting departmental procedures and devising systems for documentation requirements,

- Revise, review, and approve SOP’s, planned and unplanned deviations, CAPA, Batch Manufacturing Records (BMRs) and all other aspects of cGMP compliance,

- Monitor Non-Compliance reports and take corrective actions to assure timely completion,

- Document Change Control: Maintain a system for Document Change Control that requires review, approval and issuance prior to use. The system will require minimum bi-annual review and update
(DCCR),

- Deviation System: Maintain deviation reports of discrepancies, failure of a batch or its components and investigate whether or not batch has been released (DR),

- Corrective and Preventative Action System (CAPA): Maintain records of the corrective and preventative steps to resolve non-conformances,

- Preventative Maintenance and Calibration: Maintain a schedule for PM and calibrations and document results,

- Other duties as assigned by the Director of Quality.

Qualifications & Experiences:

- B.S degree preferred and a minimum 5-7 years GMP experience,

- Minimum 5-7 years in Quality Assurance working in a pharmaceutical or biological company,

- Experience in management,

- Experience working in a paper based GMP documentation system as well as working with or maintaining Document Change Control System, Deviations, Out of Specifications, CAPAs, training records and materials management,

- Experience with Batch Record Review and Release of product,

- good knowledge of Microsoft Word, Excel, and Outlook.


You will be working in a modern, professional, fast growing internationally active organization with a high degree of responsibility and independence. Intensive on-the-job training will be provided in a competent multidisciplinary team. We offer a competitive salary package and support professional development.

Should you be interested in the above position and wish to apply, please send your application to: janera.harris@cytonetllc.com


***


Production Associate

Summary:
Cytonet LLC, a company specializing in the manufacturing of primary liver cells for cell therapy applications in the US and Europe in the field of cellular and biological therapeutics is seeking an entry level Production Associate.

Essential Functions:

- Production of human primary cell using accompanying documentation according to GMP guidelines.

- Maintenance and cleaning of equipment.

- Preparation of materials for washing and sterilization

- Maintenance, cleaning, and environmental monitoring of GMP/clean room areas and

- Reviewing and revising of operating protocols, reports and SOPs according to GMP guidelines.

- Execution of process validations for the production of human primary cells.

- Maintenance of documentation and logbooks.

- Must be able to work in a clean room environment with Personal Protective Equipment

..(confined area)

- Acceptance of incoming livers into the facility for processing

***Must be able to work a flexible on-call schedule including weekends and holidays***


Qualifications:

- Associate’s Degree in science or a related field.

- 0-3 years experience in a FDA and/or EU GMP regulated environment

- Familiarity of FDA and/or EU manufacturing/regulatory quality systems regulations

- Experience working in a clean room environment or biological containment facility

- Experience working with tissue/primary cells is preferred, but not required

- Knowledge of aseptic technique

- Ability to read and follow Standard Operating Procedures

- Must possess strong motivational skills and be able to work in a team environment.

- Must be detailed oriented and have excellent organizational skills

- Must possess effective written and oral communication skills

- Must be able to work in multi-faceted operation

- Experience with Microsoft Word, Excel and Outlook.

Point of Contact: Sonya Meheux, sonya.meheux@cytonetllc.com