Associate I, QC Bioanalytics Solstice Neurosciences
THIS JOB HAS EXPIRED Position Summary
Quality Assurance Compliance Associate I/II supports the Quality Assurance Compliance group in a biopharmaceutical company.. The candidate should have a good understanding of cGMP requirements. The position requires an individual who can work well independently as well as in a team environment. The position also requires a high degree of accuracy and attention to detail.
Compliance Responsibilities include:
Participate in/support internal audits
Compile data in support of material and service provider quality metrics
Compile data in support of quality system process metrics
Assist in the investigation of non-conformance events, such as, out of tolerances, out of specifications, deviations, product complaints, etc.
Assist, as needed, in facilitating timely completion of corrective and preventive actions.
Lot disposition responsibilities include:
Review and disposition of materials
Review of records for intermediates to ensure completion, correctness and conformance to SOP requirements and specifications.
Review of records for formulated bulk drug and (labeled or unlabeled) Final Container to ensure completion, correctness and conformance to SOP requirements and specifications.
Assist in assembling Lot Release Protocols
Provide data verification for Lot Release Protocols, CMC data packages, and submissions.
Maintain GMP records and files within QA.
Works to meet schedules, timelines, deadlines
Serve as a QA team member in meetings
Notify Management of potential quality or regulatory issues that may affect product quality
Provides support during partner audits and regulatory inspections
Participate in group projects and process improvements
Assist in training of Solstice staff
Provides operational support for other QA functions.
Knowledge and experience in US and EU cGMP, preferably in a commercial biopharmaceutical organization.
Excellent organization and documentation skills.
Computer skills, including Microsoft Word, Excel, and Access
BA or BS in a scientific discipline with 2-5 years of industry experience, 1-3 years in Quality Systems or Quality Assurance departments working directly with product complaints and conducting audits or other Quality System Elements such as Change Control, Document Control, CAPA, or Supplier Quality in a commercial cGMP environment, preferably in a pharmaceutical/ biotechnology/medical device company.
||San Francisco, CA |
THIS JOB HAS EXPIRED