Sr. Quality Control Specialist
- Employer
- Dynavax Technologies
- Location
- Berkeley, CA, US
- Start date
- Mar 7, 2019
View more
- Discipline
- Clinical, Clinical Medicine, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
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Job Details
Overview
Perform Quality Control (QC) activities in collaboration with others in support of project deliverables. The incumbent at this level will execute and complete QC tasks based on methodologies and approaches that are usually predetermined. The incumbent will work in a QC environment, but must have the flexibility to work in an analytical development environment
Responsibilities
Qualifications
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Perform Quality Control (QC) activities in collaboration with others in support of project deliverables. The incumbent at this level will execute and complete QC tasks based on methodologies and approaches that are usually predetermined. The incumbent will work in a QC environment, but must have the flexibility to work in an analytical development environment
Responsibilities
- Perform QC testing of drug substance and drug product samples in support of in-process, lot-release, and stability testing by following written procedures.
- Use good documentation practices to record original test data.
- Perform peer review (technical and compliance) of data generated by other QC team members.
- Independently draft study protocols and data summary reports.
- Coordinate laboratory maintenance activities, including the monitoring of supply inventories and equipment calibration status.
- Independently develop and document QC systems and procedures, with particular attention to issues of cGMP compliance.
- Independently draft and revise written test methods as required.
- Independently perform test method development, optimization, qualification, and validation as required.
- Design and implement technical, compliance (cGMP) and QC systems training programs for junior team members under management supervision.
- Work as a member of a fully-integrated team.
- Participate in the direction of QC analytical method troubleshooting and in investigations of OOS/OOT results.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- Must be a team player with good communication skills and be able to communicate scientific work performed to the team.
- Other duties as assigned.
Qualifications
- BS in chemistry, biochemistry, or other related science and 10+ years' relevant experience.
- Proficient in Microsoft Office Suite - Word, Excel, PowerPoint, etc.
- Broad knowledge and experience performing assays used to assess the quality of biopharmaceuticals, including HPLC, SDS-PAGE, CE, etc.
- Must have documented GMP training from a recognized source.
- Proven experience with analytical method optimization, development and/or validation and troubleshooting.
- Experience participating in laboratory investigations of OOS/OOT results.
- Experience in designing and implementing training programs for entry-level laboratory staff.
- Experience in preparing for or participating in laboratory compliance audits and/or inspections by regulatory agencies.
- Experience in preparing reports or data summaries for submission to regulatory agencies.
- Excellent written communication skills and proven ability to translate technical data into concise narrative/summary.
- Ability and desire for problem-solving and decision-making in a cross-functional team setting.
- High attention to detail, excellent organizational skills, and ability to work on multiple projects with tight deadlines.
- Excellent interpersonal and verbal communications skills, and ability to deal effectively with a variety of personnel, both inside and outside the company.
- Flexible, high level of integrity, action- and goal-oriented.
- Enjoy a fast-paced, team-oriented, and collaborative environment.
- Proven ability to establish collaborative working relationships, but able to work independently.
- Other duties as assigned.
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Company
We are developing immunotherapies based on cutting-edge Toll-like receptor (TLR) biology and its ability to modulate the immune system.
Company info
- Website
- http://www.dynavax.com/
- Mini-site
- Dynavax Technologies
- Phone
- 510-848-5100
- Location
-
2100 Powell Street
Suite 300
Emeryville
California
94608
US
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