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Akorn, Inc.
- Cranbury, NJ
QA Manger will primarily oversee and manage activities within the QA Document group. QA Manager will be responsible for Change Control Management, Document Change Control Management, Controlled Document Storage Room and Archival Management, Technical Review Board (TRB) Meetings, Investigation Review Board Meetings (IRB), and other typical managerial responsibilities. Responsibilities include inter
Posted 1 day ago
Reviews, coordinates, and assists to ensure non conformance's are adequately investigated for determination of root cause and product impact per FDA regulations. In addition, ensures that corrective and preventive actions (CAPA) are identified and implemented to prevent/reduce reoccurrence. Oversee product complaint investigation process to ensure they are adequately investigated, within defined t
Posted 2 days ago
All Compounders are responsible for all activities associated with the manufacturing and filling operations, required to produce sterile drug products under aseptic conditions. ESSENTIAL FUNCTIONS Include the following. Other duties may be assigned. Formulate and compound sterile products under aseptic conditions. Filling of sterile products under aseptic conditions. Weighing and staging of raw ma
Posted 14 days ago
All Production Line Operators are responsible for all activities associated with the manufacturing and filling operations, required to produce sterile drug products under aseptic conditions. ESSENTIAL FUNCTIONS Include the following. Other duties may be assigned. Compliance with associated SOPs and training requirements Basic understanding of personnel, equipment flow and controlled environments P
Posted 14 days ago
The Metrologist in R&D will perform activities associated with Maintenance, Calibration and data management of Formulation equipment such as homogenizers and Pilot Lab equipment and analytical instruments such as HPLC, UPLC, and GC. Coordinates with Data Integrity group to assure and maintain data integrity for Computerized Data Systems. Coordinates preventive maintenance activities of formulation
Posted 15 days ago
All Packaging Operators are responsible for all activities associated with the finishing operations of sterile and non sterile manufactured drug products. These activities listed within this posting are requirements of the position. However, these requirements are subject to change with the creation of new products introduced in future expansions within current facilities. ESSENTIAL FUNCTIONS Incl
Posted 15 days ago
Special projects assigned. Auto req ID 1848BR State New Jersey City Somerset Qualifications QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the
Posted 15 days ago
Other duties may be assigned Responsibilities include interviewing, hiring, training, planning, assigning and directing work, appraising performance, rewarding and disciplining employees, addressing complaints & resolving problems. Auto req ID 1817BR State New Jersey City Somerset Qualifications EDUCATION AND EXPERIENCE Bachelor's degree along with a minimum of three (3) years hands on and supervi
Posted 15 days ago
The Facility Mechanic Specialist works under the facilities Department to help maintain daily operations at the Somerset, NJ manufacturing facility. Responsible for troubleshooting and repairing systems and equipment modules. ESSENTIAL FUNCTIONS Include the following. Other duties may be assigned. Responsibilities to the maintenance crew involved in the maintenance and installation of mechanical e
Posted 21 days ago
All Packaging Operators are responsible for all activities associated with the finishing operations of sterile and non sterile manufactured drug products. These activities listed within this posting are requirements of the position. However, these requirements are subject to change with the creation of new products introduced in future expansions within current facilities. ESSENTIAL FUNCTIONS Incl
Posted 21 days ago
Responsible for the overall direction, coordination and evaluation of this unit, and the compliance and integrity of data at the Somerset site. SUPERVISORY RESPONSIBILITIES Responsible for performance reviews, goal setting and personnel development plans for Quality Assurance Data Reviewers, and Quality Control Investigators Providing regular performance feedback (praise and developmental) to memb
Posted 22 days ago
Akorn, Inc.
- Philadelphia, PA
Staff conventions as directed by sales management. Auto req ID 1876BR State Pennsylvania City Philadelphia Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities
Posted 30 days ago
Reviews, coordinates, and assists to ensure nonconformances are adequately investigated for determination of root cause and product impact per FDA regulations. In addition, ensures that corrective and preventive actions (CAPA) are identified and implemented to prevent/reduce reoccurrence. Oversee product complaint investigation process to ensure they are adequately investigated, within defined tim
Posted 2 months ago
The QA Investigations Specialists review, coordinate, and assist to ensure non conformances are adequately investigated for determination of root cause and product impact per FDA regulations. In addition, the QA Investigations Specialist ensures that corrective and preventive actions (CAPA) are identified and implemented to prevent/reduce reoccurrence. Oversee product complaint investigation proce
Posted 5 months ago
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