Quality Assurance Analysts - NW of Houston, TX (Direct Hire)
Company: Careerbuilder-US
Location: Conroe
Posted on: January 12, 2021
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Job Description:
Kelly Science is currently recruiting candidates for several
Quality Assurance Analyst positions at a biopharma company NW of
Houston TX. The Quality Assurance Analyst will be responsible for
review and/or approval of basic and technical documentation,
drafting and reviewing of internal Quality policies and procedures,
performing product related activities, performing Quality audit
functions, identifying process and Quality System improvements, and
acting as a QA liaison internally and externally.Job
Responsibilities:* Review and/or approve basic and technical
documentation with minimal supervisory oversight to include, but
not limited to: * Standard Operating Procedures* Batch Production
Records (completed and approval)* Commissioning, qualification and
validation protocols and reports* Deviation Reports* Corrective
Action/Preventive Action Plans* Technical / QC data review and
approval* Drug Substance/Product Reports* Trending QA data* Draft
and review internal Quality policies, procedures and reports.*
Perform inspection of final product containers and review and/or
approval of executed process records and data.* Perform Quality
audit functions to include, but not limited to: * Audit of lab
notebooks* Audit of equipment logbooks* Review of vendor, supplier,
contract laboratory audit questionnaires* Lead vendor, supplier,
contract laboratory and client audits* Identify process and Quality
System improvement opportunities.* Provide daily guidance for the
compliance of the QA department to national and international
standards and regulations.* Support Regulatory, client, and
internal audits.* Act as QA liaison to internal Departments and
external Client Quality Groups and Vendor/Contract Laboratory
Quality Groups.* Promptly notify Senior Management of potential
quality or regulatory issues that may affect product quality or
regulatory compliance.* Assist with compliance related
functions.Job Requirements:There are multiple levels of positions
available for varying levels of education, BS and MS, and years of
Quality Assurance experience supporting pharmaceutical,
biopharmaceutical or biotechnology products. Some exposure to good
documentation practices, cGMP/GLP regulations is required.These are
direct hire positions with compensation commensurate upon level of
education and applicable experience.If you meet the above
qualifications, please submit your resume for immediate
consideration.Why Kelly--?Kelly-- Science & Clinical is your
connection to premier scientific and clinical companies looking to
hire talented people just like you. Every day, we match science
professionals with dream jobs that fit their skills and
interests-it's the way we think job searching should be. Nearly 100
percent of our science recruiters have a professional
background/education in science, so we know a thing or two about
the science market and how to get you noticed. About Kelly--At
Kelly, we're always thinking about what's next and advising job
seekers on new ways of working to reach their full potential. In
fact, we're a leading advocate for temporary/nontraditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live. Connecting great people with great companies is what we
do best, and our employment opportunities span a wide variety of
workstyles, skill levels, and industries around the world. Kelly is
an equal opportunity employer committed to employing a diverse
workforce, including, but not limited to, minorities, females,
individuals with disabilities, protected veterans, sexual
orientation, gender identity. Equal Employment Opportunity is The
Law.
Keywords: Careerbuilder-US, Conroe , Quality Assurance Analysts - NW of Houston, TX (Direct Hire), Other , Conroe, Texas
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