Quality Control Analyst II

HireLifeScience; Fort Worth (TX); On-site; USD 60,000 - 90,000; Full time

Job summary

HireLifeScience in Fort Worth, TX is seeking a laboratory analyst to support quality control and analytical testing. You will perform routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, and stability samples, using capillary electrophoresis and HPLC/GC techniques.

Responsibilities include method development and qualification, documenting results, regulatory compliance, writing reports, assisting audits, and training junior analysts.

Responsibilities

• Perform routine and non-routine analyses of in-process materials, raw materials, finished goods, or stability samples.
• Coordinate testing with contract laboratories and vendors.
• Write technical reports, deviation reports, and testing protocols.
• Review data for regulatory compliance and accuracy.
• Calibrate, validate, or maintain laboratory equipment.
• Participate in internal assessments and audits as required.
• Train other analysts to perform laboratory procedures and assays.

Skills

Capillary electrophoresis

Instrument qualification

Quality control

Tools

HPLC/GC

Calibration and validation

Job description

Description:

Preferred experience:

• Capillary electrophoresis
• HPLC/GC
• Instrument qualification

• Ensure that lab cleanliness and safety standards are maintained.
• Develop and qualify new testing methods.
• Train other analysts to perform laboratory procedures and assays.
• Perform visual inspections of finished products.
• Participate in internal assessments and audits as required.
• Identify and troubleshoot equipment problems.
• Evaluate new technologies and methods to make recommendations regarding their use.
• Serve as a technical liaison between quality control and other departments, vendors, or contractors.
• Coordinate testing with contract laboratories and vendors.
• Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses.
• Write or revise standard quality control operating procedures.
• Supply quality control data necessary for regulatory submissions.
• Receive and inspect raw materials.
• Review data from contract laboratories to ensure accuracy and regulatory compliance.
• Prepare or review required method transfer documentation including technical transfer protocols or reports.
• Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
• Participate in out-of-specification and failure investigations and recommend corrective actions.
• Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols.
• Investigate or report questionable test results.
• Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
• Identify quality problems and recommend solutions.
• Evaluate analytical methods and procedures to determine how they might be improved.
• Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
• Calibrate, validate, or maintain laboratory equipment.
• Compile laboratory test data and perform appropriate analyses.
• Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.

Custom Fields:

• Name: Badge ID Required Value: Yes
• Name: Worker Time Type Value: Full Time
• Name: Invoice Type Value: USA-ARL-Staffing-USD
• Name: Workspace Value: None
• Name: Work Desk Phone Number Required Value: No
• Name: Remote Worker Value: No
• Name: System Access Required Value: Yes
• Name: Supervisory Org Value: FWM AS&T Micro and Analytical Standards(James Brandon Pittman)-60002312