Within this role you will be responsible for supervising the laboratory quality control testing of a variety of raw materials, products, in-process materials, or stability samples in support of the company’s quality program.
As a Supervisor Quality Control within the HPLC...
...microbiological or biological analyses on raw materials, products, in-process materials, or stability samples in support of the company’s quality program.
Capturing data and documenting test results.
Completing test records and reviewing data.
Calibrating or verifying...
We are currently looking to fill a Quality Compliance Specialist - Change Control position on the Quality Assurance Change Control Team. This role works within the QA Change Control Team to primarily facilitate activities and relationships regarding change controls and partner...
...Summary: The Quality System Specialist participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Engineering, Materials Handling, and QA Validation in...
Summary: The Quality Compliance Coordinator supports data trending, process monitoring, and system administration activities to ensure overall... ...(QMS). This position will focus on Deviation, CAPA, Change Control and Quality Risk Management elements of the QMS.
Essential...
...role you will be responsible for managing and overseeing Document Control and Archives operations. This includes oversight of the... ...performance and providing monthly metrics for presentation; includes Quality Operations systems metrics
Acting as the voice of Doc Control...
...expertise, leadership, oversight and assisting with strategic planning for the Regeneron Industrial Operations and Product Supply (IOPS) Quality Auditing function. Quality (GMP) Auditing is responsible for maintaining the external audit program and performing external audits...
...applications and systems.
As a Senior IT Applications Analyst within Quality Systems a typical day might include, but is not limited to, the... ...(tabular, trend and labels)
Processing IT Applications change control requests
Working with Validation and Quality departments to...
...internal procedures as well being the key liaison between the IT and Quality Assurance groups.
As a IT Compliance Analyst, a typical day... ...Technical Writing assistance with the management of Change Controls, Deviations, CAPAs
Provides Technical Writing assistance with...
...Batch Release) ensuring that inspection procedures are followed at all times and that all product and paperwork passes specified quality control requirements before shipping to customers.
Reporting to: Supervisor, Quality Control
Ensure that all products which...
...Providing leadership and ensuring continuous improvement to the Quality Training System and the GMP Program according to GMP and current... ...activities such as internal audit, inspection preparation and change control as required.
Collaborating with subject matter expert(s) and...
...implementation of safety improvements.
Interfaces with other departments, such as Facilities, Process Sciences, Regulatory, Quality Assurance and Quality Control.
Leads and implements process improvements and robustness initiatives.
Prepares and presents manufacturing data...
...investigation and deviation management. The Compliance Analyst will report quality system metrics to the group and identify improvements that can... ..., GLIF investigation, corrective and preventive actions, change control and standard operating procedures
Reporting quality system...
...You would also be responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas... ...calibration
Performing all duties relevant to the Quality Control Microbiology Analyst position as required
To be considered for...
...Assisting with the improvement effort of streamlining the review and release process
Attending meetings as required on behalf of Quality Control to update partners (Drug Supply, External Manufacturing, QA) as to status issues pertaining to release data
Attending meetings...
...procedures.
Writes, reviews, Standard Operating Procedures or other controlled documents as needed.
Provides technical input to resolve... ...Responsible for modifying process method files through the quality system.
Supports CAPA implementation on process related improvements...
...related support equipment with strict adherence to SOPs, cGMPs, and quality standards
Identify any off-nominal conditions with mechanical... ...this includes generating and completing critical systems change control and interact with and oversee contractor/vendor work
Adhere...
...equipment and update old equipment SRS/ SIA. Defining standards, controls, and procedures across the lifecycle of documents.
Contact... ..., Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
Equipment SME with respect to...
...departments on projects developing, implementing and enhancing the system
Processing IT Applications change control requests
Working with Validation and Quality departments ensuring IT Applications are implemented following development life cycle approach
Providing...
As a TempProject Specialist will lead well-defined Quality Control projects. You may additionally support, plan and coordinate operational tasks for other QC projects under the guidance of a Portfolio/Program Manager.
This is a 12-month temporary contract.
A typical day...
...requirements, supervising the compliance team in relation to completion of quality instances for the Manufacturing departments.
As a Supervisor... ...metrics including deviations, corrective actions and change controls.
Ensures audit readiness and coordinates where required....
...process materials, or stability samples in support of the company’s quality program.
As a QC Analyst within the Biochemistry Lab, a... ...product, stability, and/or research samples
Writes and revises control test procedures and SOPs
Completes test records and reviews data...
Responsible for providing expertise and leadership in the Quality function. Responsible to ensure that licensed product is certified and... ...and Fill/Finish manufacturing operations, facilities and Quality Control laboratories to ensure a successful compliance profile....
...you will be responsible for the management and leadership of the Quality Assurance Operations function. This role will be part of the QA... ...industry best practices for cGMP across manufacturing, quality control, materials management, and validation.
As an Associate Director...
...manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process... ...non-viable particulate air monitoring of aseptic operations and controlled areas
Performing acceptance testing of commercially prepared...
...Compliance Specialist will be responsible for managing QC's Change Controls/CAPAs and Workflows.
In this role a typical day might include... ...to, the following:
Coordination and documentation of QC quality records including but not limited to, Change Control’s /CAPA's and...
...Providing Instrumentation/Calibration support to Facilities, Quality Assurance Team, Engineering and Operations
Adhering to and remaining... ...be for you if:
You have the ability to work with automated control systems and with low voltages
You have the ability to loop...
...reports and technical expertise
Leads operations for new technologies and new product development
Collaborates with Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners...
...readiness program, and follow, foster and implement on daily basis a quality culture and any other company manufacturing standards, policies... ...operations.
Strong background and familiar with site change control, risk management and data integrity initiatives/programs....
...in a structured manner and the customers are offered the highest quality standards and value for money, whilst at the same time achieving... ...Bone Gastropub with specific responsibility for training, stock control, payroll management/rostering and cash procedures.
We are...