Quality Assurance Associate

Armata Pharmaceuticals Marina Del Rey , CA 90295

Posted 2 weeks ago

About this position:

The QA Associate, under the direction of the Manager of QA, will support process

development, manufacturing and clinical operations by assisting in the implementation and

maintenance of quality systems that ensure compliance with internal and regulatory

requirements and expectations.

Job description and technical requirements:

  • Partner with Production and Facilities, Quality Control, Clinical Operations and other

operations colleagues in ensuring high quality products and compliance with current Good

Manufacturing Practices (cGMPs) and Good Clinical Practices (GCPs)Assist in reviewing and processing Batch Production Records (BPR), Non-Conformances

(NC), Standard Operating Procedures (SOP), Forms, Reports, and equivalent documents

through the Document Control system.

  • Support the implementation and maintenance of other quality systems including, but not

limited to change control, internal and external audits, GMP training, and validation

  • Collaborate with operations colleagues on deviation investigations and ensure the timely

completion of corrective and preventive actions (CAPAs)

  • Support quality assessments of internal operations to analyze quality compliance and

assess risk

  • Assist in the conduct of internal and external audits to ensure GMP compliance

  • Understand and comply with company standard operating procedures and safety

procedures

  • Other duties as assigned

Qualifications and Experience:

  • Prior experience in the biotechnology or pharmaceutical industry is required

  • Must have a Bachelor of Science (BS) degree

  • Minimum of 3 years of hands on experience using quality system processes such as

investigations/CAPAs, change control, document management, validation, training,

supplier qualification, internal/external audit, material release, batch release/disposition

  • Minimum of 3 years of experience in a GXP regulated environment

  • Strong technical writing skills including experience authoring QA SOPs

  • Strong verbal and written communication skills

  • Strong working knowledge in Microsoft Office applications is required

  • Must be reliable, organized, detail oriented, and self-motivated

  • Strong team-player and able to work well in small groups and independently

Physical Working Conditions:

This is a full- time position for work in a laboratory environment. The position requires wearing personal protective equipment. Occasionally, may require lifting or moving equipment up to 20 pounds and may require standing for extended durations throughout the day. Upon request, reasonable accommodations will be offered to enable individuals with disabilities to perform essential functions. There is little to no travel required of this position, with the exception of required training and possible conference or event attendance.

About Armata Pharmaceuticals, Inc.:

Armata is a clinical-stage biotechnology company focused on the development of pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific cGMP manufacturing.

Pay: $75,000 - $85,000 per year

Send cover letter and CV to: careers@armatapharma.com


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