Quality Control Analyst III, Analytical

Role Title - Quality Control Analyst III, Analytical

Department- QC

Reports to- QC Manager, Analytical

FLSA -Exempt

Salary Range: $80k- $90k

CORE VALUES

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

COMPANY DESCRIPTION

Polaris Pharmaceuticals, Inc., an affiliate of the Polaris Group (www.polarispharma.com), is a therapeutic protein drug manufacturer located in Vacaville, California. Polaris has a cGMP facility producing biological study drugs to support all Polaris Group clinical trials at various stages in the USA, Europe, and the Asian-Pacific region.The lead project of the company is now in clinical trials for patients with different types of cancer including mesothelioma, sarcoma, and glioblastoma. Polaris is seeking candidates to help with the production of this protein drug as well as the production of products for our clients and partners.

ROLE SUMMARY

The Quality Control Analyst, under direct or minimal supervision, is responsible for performing biochemical, physical, and chemical evaluations of process development, lot release, and stability samples compliant with cGMP guidelines. The Analyst works independently on assays that he/she has mastered. This position requires willingness to undergo training on more advanced analytical methods and always employs laboratory safety policies. The Analyst will be responsible for the timely completion of assignments. Good record keeping, organizational, written, and verbal communication skills are essential. The analyst must be willing to work overtime as required.

ROLE RESPONSIBILITIES

• Performs, under direct or minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
• Reviews test data for accuracy, data integrity, system suitability, and conformance against defined criteria/specifications.
• Provides technical support with troubleshooting of test methods, as needed.
• Identify and contribute to OOS/OOE/OOT investigations related to testing performed.
• Initiate and author deviation and laboratory investigations.
• Maintains the laboratory in an inspection-ready state.
• Develops and maintains proficiency in a broad range of trained test methods.
• Train analysts on test methods and procedures.
• Responsible for authoring Change Control records and leading the revision of written procedures as assigned.
• Holds self and others responsible to abide by department and company policies and practices.
• Adheres to cGMP, 21CFR, USP, EP, ICH, and other applicable regulatory requirements.
• Manage reagent and equipment inventory for assigned areas of responsibilities.
• Responsible for sampling and testing of incoming raw materials

SKILLS

• Strong working knowledge of cGMP regulations, including 21CFR 210 & 211, USP, EP, and ICH.
• Ability to follow written instructions and to perform tasks with direct or minimal supervision.
• Works independently as well as in a team environment.
• Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel.
• Good written, verbal, and communication skills.
• Strong documentation skills a must. The analyst must develop skills in the operation and routine maintenance of various analytical instruments and computers.

The analyst must develop the skills necessary to understand the operation of the equipment and gain knowledge of the equipment used for testing and to use these skills in the event of an unexpected result caused by equipment or reagent failure that warrants a laboratory investigation. Experience with Protein analytics, SDS-PAGE, separations technology for HPLC, Chromatography Data Systems (CDS) software such as OpenLab, subvisible particles testing (USP <788>), and CCIT preferred. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

QUALIFICATIONS

B. S./B. A. in Science/Related Field (major in biology-biochemistry-chemistry). Minimum of 5 years of relevant laboratory experience is desired.