R&D Partners is seeking to hire an Associate, Clinical Quality in Novato, CA.

Benefits of this role:

Competitive pay

Full-Time role

Benefits + 401k

Your main responsibilities as an Associate, Clinical Quality:

Review of GMP documentation from Pilot Plant, CDMOs, Analytical Sciences, including log books, batch records and test records.

Issuance of Batch Records for clinical production

Review and approval of procedures and batch records related to early phase programs(Quality, Pilot Plant, Analytical Sciences, other areas).

Review and approval of quality system records including change requests, deviations and CAPA for Technical Development (i.e. Pilot Plant, Analytical Sciences, Process Development).

Oversee manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations.

What we are looking for in an Associate, Clinical Quality:

Bachelor's degree in scienfitic field.

Minimum 3 years of experience in a Quality/Compliance/Regulatory setting

Sound knowledge of cGMPs and equivalent industry regulations

Prior experience with oversight of manufacturing or testing operations

Proficiency with computer systems Microsoft Office Suite

Why Choose R&D Partners?

Supportive teams

Ongoing contracts

Weekly payroll

Refer a Friend bonus

Pay Scale:

$31.02 - $38.78 (Dependent on Experience)

R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal opportunity employer.