Quality Assurance Specialist in Berkeley, CA at Apex Life Sciences

Date Posted: 11/15/2018

Job Snapshot

Job Description

 The Quality Assurance (QA) Specialist will manage the quality documentation system, perform and/or manage the Quality activities related to the company’s development products, change management, review of master and completed batch records and release of drug product for clinical use. This is an exceptional opportunity to gain experience in a successful biotech company.

Responsibilities include, but are not limited to:

*  Perform and/or manage the Quality activities related to the company’s development (pre-clinical and Phase I-II) products

*  Manage the QA Document Management system, include filing and organizing documentation from Contract manufacturing organization (CMOs).

*  Assists in review and release of batch records and corresponding documentation prior to product disposition.

*  Review, approve, and make effective master formulation records, master manufacturing records, specifications, CTM labels, and other quality related documentation

*  Assists and manage in establishing Standard Operating Procedures (SOPs)

*  Review and approve deviations / non-conformances

*  Manage and track Lot genealogy, CMC document trackers, and quality metrics

*  Maintains training records and training record program for all personnel

*  Track stability program

*  Track retest / expiry of APIs, drug products and reference standards

*  Identify and review Quality issues, develop proposals and make informed decisions with input from QA management. Implement decisions and/or corrective actions, etc. concerning development products

*  Other duties as assigned

Position Requirements & Experience:

*  Bachelor’s degree in related field required (or relevant experience)

*  At least 3 years of experience in a cGMP QA and/or pharmaceutical laboratory environment – preferred

*  Independent decision making with a high degree of initiative

*  Detail and team oriented

*  Desire to learn and tackle new challenges is imperative

*  Comfortable in a fast-paced small company environment with minimal direction and adjust workload based upon changing priorities

*  Comfortable in a fast-paced small company environment that requires flexibility to adjusting workloads based upon changing priorities and willingness to be a team player in order to accomplish the common goal of the project, regardless of level or type of work

*  Advanced Skills with Microsoft Office Suite (Word and Excel)

*  Specialized knowledge of QA Systems and Compliance, business principles and departmental processes

*  Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.

*  Broad to in-depth knowledge of FDA regulatory requirements for small molecules. Solid knowledge of GMP.

*  Experience review and writing regulatory IND sections a plus.

*  Clinical GCP QA exposure is a plus.

*  Audit experience is a plus.