Analyst (In-Process), Quality Control (Flex)

Avid Bioservices; Tustin (CA); On-site; USD 35,500 - 44,372; Full time

Job summary

Avid Bioservices is seeking a Quality Control In-Process Analyst in California to support manufacturing, validation, process development and stability studies in a GMP environment.

The role involves testing, buffer formulation, method writing, aseptic sampling and data reporting, with collaboration across departments to ensure compliance and successful lot release. This full-time position offers competitive pay and benefits within a leading biopharma CDMO.

Qualifications

• Bachelor's degree or 2–4+ years of biotech QC/analytical lab experience.
• Experience with analytical testing, writing reports, GMPs, and regulatory audits.
• Experience with most listed methodologies.
• Experience with maintenance and troubleshooting of analytical instrumentation.

Responsibilities

• Perform basic compendial test methods following written protocols.
• Formulate buffers and reagents for test methods.
• Write and revise test methods and procedures.
• Perform aseptic sampling, endotoxin, pH, conductivity, osmolality, A280 and endotoxin by LAL.
• Perform water testing and raw material sampling and testing.
• QC testing for lot release, development/validation projects, and investigations.
• Draft study protocols and reports.
• Collaborate with other departments to update QC procedures.
• Aware of cGMPs and applicable regulations.
• Handle sample pick up and locating per protocols.

Skills

GMP knowledge

Regulatory audits

Data analysis

Technical writing

Attention to detail

Team collaboration

Education

Bachelor's degree

Tools

Analytical instrumentation

Job description

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.

Your Role:

TheQuality Control In-Process Analystwill perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment for the Quality Control In-Process team.

• Perform basic compendial test methods without supervision and with strict adherence to written protocols, analyze data and report results.
• Formulate buffers and reagents for the purpose of performing test methods.
• Write and revise test methods and procedures.
• Perform aseptic sampling, endotoxin, pH, conductivity, osmolality, A280 and endotoxin by LAL.
• Perform water testing and raw material sampling and testing.
• Perform QC testing for lot release, stability, development/validation projects, and investigations.
• Other functions include writing study protocols and reports.
• Work with other departments in developing, revising and implementing QC procedures and policies.
• Should be aware of company cGMPs as well as industry regulations that apply to all job functions.
• Perform sample pick up and sample locating without supervision and with strict adherence to written protocols.
• Other duties as assigned.

Minimum Qualifications:

• Bachelor's degree or 2-4+ years of biotech industry experience working in a QC or analytical lab.
• Must have experience with analytical testing, writing reports, GMPs, and regulatory audits.
• Experience with most, if not all the methodologies listed above.
• Experience with basic maintenance and troubleshooting of analytical instrumentation is highly desirable.

Position Type/Expected Hours of Work:

• This is a full-time position operating Sunday through Wednesday on a 4x10(4 days x 10 hours) schedule.
• Will have an adaptable schedule to accommodate operational and scheduling demands.
• Availability needed for overtime and weekend shifts as necessary.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $25.77 to $32.21 hourly, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.