The Production Supervisor is a cross functional position encompassing, but not limited to the Supervision of the Dispensing, Granulation, Compression/Encapsulation/Tooling, Film Coating, Injection Molding, and Chemical manufacturing process.
This position is for the 2nd Shift which runs from 3pm - 11:30pm.
The Quality Assurance Compliance Training Manager is responsible for managing the Training Department, overseeing development and administration of TMS training curricula that provide comprehensive training to employees, and assures training compliance. This position will also promote compliance and a continuous improvement culture to drive process and cost improvement. This position will interact with departments within Halo to critically evaluate quality systems in order to support process improvements.
Objectifs du poste
L’analyste effectue les analyses requises de matières premières et des produits finis et effectue la révision des documents générés par le laboratoire du développement analytique dans le but d'en assurer l'intégrité ainsi que la conformité aux BPL et aux MON et apporte un soutien aux membres du Développement analytique et Développement des formulations et des procédés lors de l’élaboration de nouveaux produits. Cette personne développe, améliore, valide, transfère et révise les méthodes analytiques pour les matières premières et les produits finis déjà commercialisés ou en cours de développement.
The Specialist, Quality Assurance position supports the investigation process, customer complaints and Annual Product Reviews (APR); through the quality review and approval of technical documents and investigations (laboratory, manufacturing, packaging and storage) associated with Investigation Reports (IR), Customer Complaints, and associated Corrective Action Preventive Action (CAPA). With regard to the site investigation process, the individual will: (a) provide quality, compliance and technical feedback with regard to the investigations, (b) will approve investigations on behalf of QA (when thorough and complete), and (c) will issue Action items and / or CAPAS as applicable to the investigation / complaint. Additional responsibilities will include supporting the generation of APRs and the review of APRs prior to internal circulation for Halo approval. Responsibilities will include supporting the trending associated with IRs, Complaints, Key Process Indicators (KPIs) and / or other Quality Metrics associated with the TrackWise Investigation Process.
Ancillary responsibilities include supporting regulatory and customer audits; as well as interacting with the customer to resolve / mitigate issues and concerns related to investigations and corrective action.
The Quality Assurance Compliance Specialist will fill a key compliance and regulatory position within a growing contract manufacturing company. The individual will act as the primary point of contact for suppliers / vendors in Halo’s effort to coordinate with service providers. Provide appropriate documentation to complete vendor qualification process and maintain the vendor qualification program at the Halo, Whippany NJ site. Responsible for reviewing vendor inspection questionnaires, supporting documentation and performing risk assessments. This activity may require frequent follow-up activities. The individual will be responsible for updating master sourcing list and maintaining approved vendor files.
- Perform a leadership role in qualitative and quantitative chemical analyses/experiments for Analytical Development laboratory
- Lead the method validation/transfer/verification testing for Analytical Development laboratory
- Write and review method validation protocols, reports, SOPs and investigation reports
- Perform basic pre-formulation study for various dosage forms
The Boiler Room and Utilities Operator maintains all primary facility utilities including purified water systems, high-pressure boilers, pumps, compressors, driers, generators, vacuum pumps, blowers and a chilled water plant. Prior industrial experience is required; prior cGMP experience in a pharmaceutical manufacturing environment a plus. Demonstrated safe work record required. This position requires extensive interface with facility engineers and operations personnel.