To work for a pharmaceutical manufacturing industry located in the Pompano Beach area, we're looking for a Senior Chemistry with the following experience.
JOB SUMMARY:
The Quality Control Instrument Specialist must be able to perform the duties and responsibilities
of the Senior Chemist Role and will additionally focus on support and upkeep of the Quality
Control equipment lifecycle.
This role will coordinate activities required as necessary to minimize potential impact on ongoing operations in support of business objectives and will support equipment and instrument aspects of Laboratory Investigations.
QC Chemist INSTRUMENTS SPECIALIST ESSENTIAL DUTIES AND RESPONSIBILITIES
The Instrument Specialist will work along with QC Laboratory members to perform
activities within assigned timelines and in compliance with cGMP's, regulatory requirements, company practices and procedures.
Performs testing as assigned for raw materials, in-process and finished product following written procedures and applicable pharmacopeias.
Supports QC lab activities for continuous operations. Performs data documentation and review, and releases of Lots as applicable.
Prepares samples for shipment to contract laboratories as applicable.
Provides technical validation support for laboratory equipment upgrades, replacements, and modifications in the QC laboratory. Develops and executes validation protocols (IQ, OQ, PQ) and reporting.
Performs testing, tasks, and documentation in support of Validation Studies including Process Validation, Instrument Validation, Method Validation, and development of analytical methods.
Performs testing required for raw materials, in-process and finished product following written procedures and applicable pharmacopeias.
Responsible for participating in, scheduling, coordinating, and documenting troubleshooting, calibration and maintenance performed for laboratory equipment and instrumentation.
Contributes in the selection analytical instrumentation and the establishment of laboratory systems.
Supports activities to maintain the laboratory status of compliance to FDA/regulatory standards.
Assists during internal and external audits.
Authors, reviews, and/or approves key documents such as Standard Operating Procedures, Change Controls, Deviations, Investigations, Analytical Method Validation Protocols and Reports, etc.
Promotes safe operating and working procedures.
Counsels and trains QC Chemistry employees in safety awareness related to instruments and equipment.
QC INSTRUMENTS SPECIALIST REQUIREMENTS:
BS in Chemistry or related science with a minimum of 10 years hands on experience or equivalent mix of education and experience including strong wet chemistry, chromatography and spectroscopy background.
In-depth working knowledge of laboratory equipment and troubleshooting issues.
(HPLC, GC, FTIR, ISE)
Well-developed critical thinking abilities, and the ability to identify and solve scientific problems.
In-depth knowledge of the critical functions/variables of the instrumental techniques, and proven ability to troubleshoot methods..
Knowledge of the general computerized system development life cycle in a regulated environment and software quality assurance. Experience with data acquisition software, chromatographic data systems, and data management
systems.
Knowledge of GMPs including 21 CFR parts 210 and 211. Familiarity with Section 503B of the FD&C Act, a plus.
Proven multi-tasking ability with a capability to adapt quickly in a fast-paced work environment
Extremely organized, detail-oriented and works well under tight deadlines
Strong interpersonal and communication skills, both oral and written required.
Strong coaching skills
Ability to work with others to accomplish team goals