Entries tagged with “QA” from BiotechPharmJobs.com

Quality Assurance Manager

Urgent requirement for one of our top clients located in Emeryville, CA.

Description:
Perform a variety of activities to ensure compliance with applicable regulatory requirements and facilitate the management of third-party contract manufacturing organizations. Participate in the design, establishment and maintenance of programs and processes that ensure quality products and compliance with current Good Manufacturing Practices (cGMPs) for pharmaceutical, biotech and drug/device combination products. Author, edit, review, and approve policies, SOPs, and guidance documents. Manage and administer processes within the company's Quality System. Collaborate with functional groups and contract manufacturers to evaluate and address complex issues such as deviations, technical complaints, corrective and preventive action (CAPA) and failure investigations. May lead or coordinate investigations and corrective and preventive action (CAPA) recommendations related to products. Lead or assist compliance audits (GMP, GLP, GCP, Internal and Supplier/External). Work with R&D as QA representative during new product start-ups, and identify routine checkpoints for new products and processes. Contribute to the completion of CMC sections of regulatory submissions. Provide Quality oversight for the labeling, packaging, storage, and distribution of clinical trial materials.

Requirements:

Bachelor's or Master's Degree in a relevant scientific discipline with 5+ years demonstrated QA experience in a pharmaceutical or biotech company. Prior compliance work with sterile product, aseptic manufacturing processes, or drug/device combination products is highly desirable. Must have an understanding and application of FDA regulations and guidances, QA principles, concepts, industry practices, and standards.

Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. QAM_1508, to *** anitha.maturi@makrotech.com ***

Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.

Clinical QA Auditor

Urgent requirement for one of our top clients located in Brisbane, CA.

Description:
Plans and conducts GCP audits of Company's sponsored clinical trials, CROs, vendors, clinical laboratories, internal processes, databases and clinical study reports, as necessary. Provides assurance that clinical trials are conducted and that data generated and reported are in compliance with protocols, GCP, regulatory requirements through document reviews and audits. Conducts audits to evaluate internal processes related to conduct and reporting of clinical trials to assure compliance with study protocols, SOPs, GCPs, and regulatory requirements. Issues audit reports, recommends corrective action and may conduct follow up to audits and corrective actions. Provides timely written reports to inform management of Company's regulatory status based on audits of CROs, investigator sites and internal audits of Company's processes. May participate in the management of clinical trial product complaint system. Assists in performing GCP training for internal and external customers as needed. Assists in development of Clinical QA Standard Operating procedures, as required.

Requirements:
A BA/BS degree in the sciences, R.N. or equivalent experience. Minimum of 2 years experience in the Biopharmaceutical industry including at least 1 year experience auditing clinical sites and CROs, clinical laboratories, clinical study reports, or internal systems or at least one year experience as CRA. Demonstrates a thorough knowledge of GCP federal regulations and ICH guidelines and other regulations as applicable.

Contact:
The most effective way of communication is via email please forward us your updated WORD FORMAT resume (Address, Contact number and email is must), including position of interest job No. BD_122707, to *** anitha.maturi@makrotech.com ***

Please mention your best hourly rate, availability and visa status. Any questions, do feel free to email us.

An equal opportunity employer, m/f/d/v.

Please reference BioTechPharmJobs.com when responding.