Quality Associate

Onsite, 6-month temporary opportunity with a growing and award-winning biotech company that develops novel therapeutics and vaccines for inflammatory and infectious diseases. As a Quality Associate – Environmental Monitoring, you will support the Quality Team

with the cGMP campaign. You will provide support with routine Environmental Monitoring (EM), Line Clearance, documentation, receiving inspection and Document Control functions. This position will report to the Head of Quality, Principal Investigator and Program Management.

Duties and Responsibilities:

• Perform routine environmental monitoring in Cleanrooms.
• Perform personnel plating in cleanrooms.
• Perform receiving/inspection of cGMP materials and complete associated
• paperwork following Good Documentation Practices (GDP).
• Support Quality Manager with Document Control activities such as compiling
• paperwork for SOPs, updating SOP binders, issuing batch records.
• Review documentation in support of routine Production operations (e.g.: line
• clearance and cleaning records).
• General Document Control tasks: issuance of notebooks and logbooks,
• maintaining controlled document processing/formatting, photocopying, scanning,
• filing documents and preparing documents for archive.
• Other duties as assigned or identified.

Qualifications:

• Bachelor of Science degree in the field of biology, microbiology or a related
• scientific discipline is preferred.
• 2 years of Environmental Monitoring experience in ISO Grade Cleanrooms.
• 2 years of experience in GMP and GDP (good documentation practices) in the biopharmaceutical or biotechnology industry.
• Ability to follow directions exactly as given and be capable of working with limited
• supervision.
• Proficient in Microsoft Word, PowerPoint, and Excel.
• Ability to work in a fast-paced, start-up environment.
• Good written, verbal, interpersonal, and oral presentation communications skills.
• Ability to work under pressure with changing priorities, manage several tasks at
• once and meet tight deadlines.
• Ability to work extended hours, when needed, to support Production and Quality
• Control activities.

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:

Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.

REQUESTING AN ACCOMODATION

Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.

If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) 223-4788, send us an email or speak with your recruiter.

PAY TRANSPARENCY POLICY STATEMENT

Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington

CA: $34-35/hour