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.
location: Novato, California
job type: Contract
salary: $34.23 - 40.27 per hour
work hours: 8 to 4
education: Bachelors
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
qualifications:
Required Skills:
- B.S./B.A. in Science (Major in Chemistry, Biology, Biochemistry).
- 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
- Waters HPLC, Waters UPLC, Dionex HPLC, Sciex PA800, ProteinSimple iCE3, UV/VIS Spectrophotometer, pH Meter
- 1-2+ years of Quality Control laboratory experience
- 1-2+ years of hands-on experience in separation sciences (HPLC, UPLC, CE)
skills: Chemistry, Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
