Quality Control (QC) Associate I

Aspen Neuroscience, Inc.; San Diego (CA); Hybride; USD 28 000 - 33 000; Plein temps

Avantages offerts par ce poste

Onsite gym

Medical/Dental insurance

Wellness perks

Holidays off

Résumé du poste

Aspen Neuroscience, Inc., located in Torrey Pines, CA, seeks a Quality Control (QC) Associate I to support cGMP manufacturing for a cell and gene therapy program. This on-site role requires flexibility for weekend work and is based in San Diego.

The role covers EM, raw materials, intermediates, drug product and stability testing, with emphasis on accurate data delivery and adherence to GMP standards.

Qualifications

• B.S. Degree in Biology, Cell Biology, Microbiology, Molecular Biology or Biochemistry; Or equivalent related education and experience.
• Experience working in a laboratory (academic or industry) setting and within a cGMP regulated environment is preferred.

Responsabilités

• Perform raw material inspection and sampling.
• Perform EM sampling in aseptic manufacturing environments: total particulate monitoring, active air sampling, surface and personnel monitoring.
• Assist with submission of samples to contract testing laboratories.
• Assist with organizing QC laboratories including equipment calibration.
• Conduct QC tests for raw material, intermediates, drug product, and stability samples.
• Perform test following test protocols and procedures in compliance with quality standards and cGMP regulations applicable to QC laboratory.
• Deliver cGMP compliant testing data and reports.
• Participate in investigation of deviation or out-of-specification results in QC laboratory.

Connaissances

Attention to detail

MS Office

Initiative

Teamwork

Communication

Flexibility

GMP knowledge

Formation

B.S. in Biology

Description du poste

The Quality Control (QC) Associate I will contribute to general QC operations and testing in support of current Good Manufacturing Practice (cGMP) manufacturing for an innovative cell and gene therapy program. This individual will participate in Environmental Monitoring (EM), raw material, intermediates, drug product, and stability testing program. This is an on-site role in Torrey Pines, CA that requires flexibility and availability for weekend and holiday work as needed. Relocation is not available.

DUTIES AND RESPONSIBILITIES:

• Perform raw material inspection and sampling.
• Perform EM sampling in aseptic manufacturing environments: total particulate monitoring, active air sampling, surface and personnel monitoring.
• Assist with submission of samples to contract testing laboratories.
• Assist with organizing QC laboratories including equipment calibration.
• Conduct QC tests for raw material, intermediates, drugproductand stability samples.
• Perform test following test protocols and procedures in compliance with quality standards and cGMP regulationsapplicable to QC laboratory.
• Deliver cGMP compliant testing data and reports.
• Participate in investigation of deviation or out-of-specification results in QC laboratory.

EDUCATION AND EXPERIENCE:

• B.S.Degree in Biology, Cell Biology, Microbiology, Molecular Biology or Biochemistry; Or equivalentrelevanteducation and experience.
• Experience working inalaboratory(academic or industry)settingand within a cGMP regulated environment ispreferred.

JOB SPECIFICATIONS:

• Attention to detail and organizational skills:Exceptional ability to manage tasks efficiently and maintain high levels of accuracy.
• Proficiency in Microsoft software:Demonstrated experience with Microsoft Office Suite and other Microsoft applications.
• Initiative in a dynamic environment:Strong self-starter with the ability to thrive in a fast-paced setting.
• Teamwork and independence:Capable of collaborating effectively within a team and working independently after initial training.
• Communication skills:Excellent written and verbal communication abilities.
• Flexibility: Willingness to work flexible hours, including occasional weekends, to support production needs.
• Knowledge of GMP Regulations:Basic familiarity with Good Manufacturing Practices (GMP) and industry standards

WORKING CONDITIONS

Office and Lab environment. While performing the duties of this Job, the employee is frequently exposed to toxic or caustic chemicals. This is an indoor position requiring the ability to perform experiments in the laboratory, and type and use a computer.

May work in Cleanroom for an extended period of time.

PHYSICAL DEMANDS

While performing the responsibilities of the job, the employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch, or crawl. The physical effort required is sedentary,liftingupto 10 pounds.

The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal.

These work environment characteristics are representative of the environment the job holder will encounter. Reasonableaccommodationsmay be made to enable people with disabilities to perform the essential functions of the job.

EEO and Employment Eligibility:

Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees. Aspen is not able to provide visa sponsorship for this role. Applicants must have valid work authorization that does not require employer sponsorship now or in the future.

Total Rewards and Culture:

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.

The anticipated salary range for candidates who will work in San Diego is $28.00 -$33.00 annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.