Immediate opportunity for an experienced, Specialist Product Quality, to manage change control, deviations, and compliance records for biologics and synthetic chemical manufacturing. The Specialist Product Quality will collaborate cross-functionally with Supply Chain, Manufacturing, Quality Control, Regulatory, and other teams to ensure quality and compliance.
Key Responsibilities include:
- Own and review change control, deviation records, and compliance documentation to meet project deadlines.
- Quality Review and Approval of documents, technical reports, and specifications.
- Use of various computer applications and systems for processing and tracking work items.
location: Newbury Park, California
job type: Contract
salary: $45.00 - 51.43 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- As a Product Quality (PQ) Quality Assurance (QA) Specialist, you will actively provide quality assurance support to the PQ organization as a subject matter expert of quality system records. In this team-based role you will directly add to the success of the Product Quality team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality and Process development on projects, issue resolution and investigations.
- The QA Specialist will be encouraged to use technical abilities to lead and deliver quality assurance responsibilities while owning, reviewing, and/or approving Product Quality records and documentation including: product specifications, in-process control specifications, specification technical reports, annual product reviews (APRs), international expansion forms, change control records, appendix docs (data sheets and data analysis), Deviation Investigations/Root Cause Analysis, CAPAs, analytical comparability protocols, analytical comparability reports, and procedures.
- As a team member you will be encouraged to use technical abilities to execute transactions in GMP systems (Veeva CDOCs, Trackwise, etc.) and may include additional business process support for APRs and audits, as needed. The QA specialist may also help with guiding products through the annual product review cycles at Company.
qualifications:
- Bachelor degree (BS) in Biochemistry, Chemistry, Biology, or a related protein or synthetic biotechnology sciences field with ten (10) years' experience in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment. Advanced degrees (MS/PhD) may require less experience.
- Familiar with pharmaceutical sciences, quality, compliance and regulatory GMP requirements, associated with biologics and synthetic chemical manufacturing and QC testing.
- Previous experience using VEEVA, Trackwise and Quality Compliance Systems.
- Experience with change control (owner or QA), deviations / investigations / exceptions (owner or QA), and experience in GMP environment and Quality Management systems.
- Knowledge of biopharmaceutical bulk and drug product development, manufacturing, and/or Quality Control Testing
- General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals.
- Previous experience working on a cross-functional team in a matrix environment.
- Strong project management, time management and cross-functional collaboration skills.
- Excellent written and verbal communication skills, including facilitation and presentation skills.
skills: Quality Assurance, CAPA, Biology, Chemistry, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
