Quality Assurance (Clinical)

Quality Assurance (Clinical)
  • $1 - $37.25 per Hour
  • Temporary
  • Rockville MD, US Rockville MONTGOMERY US 20852
Job Ref: JO000125210
Sector: Clinical
Sub-sector: Quality
Date Added: 10 November 2021

Key responsibilities:
• Provides Quality Oversight for the production areas including Upstream and Downstream Bulk Drug Substance Manufacturing, Warehouse, Laboratories, and Facilities
• Perform reviews of reports and data in support of regulatory filings.
• Reviews GMP related documentation such as SOPs, Technical Reports, Validation Reports
• Supports change control records under the supervision of QA Management
• Supports audits and Inspection Readiness efforts including making sure that area documentation is accurate and reviewed in a timely manner
• Works across multiple value streams to drive continuous improvement and promote quality culture
• Utilizes and continuously improves the GPS standards (i.e., 5s, standard work, problem solving, Gemba, process confirmations, and performance management) towards the goal of Zero Accidents, Zero Defects, and Zero Waste
• Work closely with cross site teams to drive performance of product disposition
• Represent QA on product/project teams and in work group meetings
• Performs other functions as necessary or as assigned
REQUIRED Qualifications:
• Associates degree in Technical/Scientific discipline
• 1 to 2 years of Manufacturing, QA, QC, process/product development experience or similar
• Some knowledge of cGMP’s and other Regulatory requirements
• Demonstrate initiative and analytical problem-solving skills
• Ability to work well under high pressure and deadlines
• Must be flexible, adaptable, and a strong team player that fosters and promotes company Values, Behaviors and Strategies.
• Good verbal and written communication skills.
• Conflict resolution and interaction management skills

Per our client’s policy, individuals hired for this position must be fully vaccinated against COVID-19 unless otherwise prohibited by law. We comply with federal, state and local laws with regard to accommodations related to this policy.

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

11/03/2022 12:00:00
USD 1.00 37.25 Hour
Contact Consultant:
Sam Royall

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