Job Title: QC Analyst

Duration: 12 Months

Location: Novato, CA, USA

Pay Range: $40 per hour

Intelliswift Software Inc. conceptualizes, builds, and supports the world's most amazing technology products and solutions. Our team of rich experts from diverse backgrounds contributes to making Intelliswift one of the most reliable partners in IT and Talent solutions. We specialize in delivering world-class Digital Product Engineering, Data Management and Analytics, and Staffing Solutions services to Fortune companies, SMBs, ISVs, and fast-growing startups.

Description of responsibilities:

The QC Analytical Analyst, under minimal supervision, is responsible for the timely completion of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines and procedures.
The Analyst works independently on assays they have mastered and performs advanced assays for multiple products. Work assignments will encompass performing and documenting activities and requires the ability to recognize deviations from approved procedures. Good record keeping, organizational, and written and verbal communication skills are essential.
The Analyst is expected to demonstrate strong cGMP and compliance acumen, become a subject matter expert for regulatory inspections, and provide training and educational development of other staff.

RESPONSIBILITIES
Performs, under minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines. General cGMP lab experience at the Analyst level.
Works independently on assays they have mastered
Develops and maintains proficiency in a broad range of test methods
Develops a technical understanding of each assay and assists with trouble shooting and laboratory investigations
Evaluates data against defined criteria/specifications
Actively applies knowledge in non-routine situations using a thorough understanding of the work processes and practices
Identifies key issues in complex situations, analyzes problems, and makes sound decisions
Assists in the revision of written procedures, method/equipment validation, and/or method transfers as assigned
Mentors and trains other analysts, including new hires and more junior analysts, in areas of expertise
Holds self and others accountable for adherence to department and company policies and practices
Maintains a safety and quality focused culture

EXPERIENCE
Required Skills:
1-2 + years of experience in a cGMP/GLP laboratory
1-2+ years hands-on experience in separation sciences (HPLC, UPLC, CE)
Ability to follow written instructions and to perform tasks with direct or minimal supervision
Strong leadership skills demonstrated through past work history
Use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel
Good written and verbal communication skills
Attention to detail and strong documentation skills
Ability to contribute effectively in team environments and independently

Desired Skills:

1-2+ years of Quality Control laboratory experience
1-2+ years of hands-on experience in separation sciences (HPLC, UPLC, CE)

EDUCATION
B.S./B.A. in Science (Major in Chemistry, Biology, Biochemistry).

EQUIPMENT
Waters HPLC, Waters UPLC, Dionex HPLC, Sciex PA800, ProteinSimple iCE3, UV/VIS Spectrophotometer, pH Meter

Intelliswift is committed to fair and equitable compensation practices. The range provided for this position is determined by various factors including, but not limited to, relevant work experience, skills, certifications, and location. Intelliswift offers medical insurance, dental insurance, vision insurance, supplemental life and AD&D insurance, and any other benefits per state law.

Equal Employment Opportunity Statement Intelliswift celebrates a diverse and inclusive workforce. We offer equal employment opportunities to all applicants and employees. All qualified applicants will be considered regardless of race, color, sex, gender identity, gender expressions, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other protected basis under the law.

Americans with Disabilities Act (ADA)

If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please contact Intelliswift Human Resources Department

Other Employment Statements
Intelliswift participates in the E-Verify program.

Learn More For information on Intelliswift Software, Inc., visit our website at .