QA Specialist - Level 2

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Focusing on immune diseases like HIV that affect a large percentage of the population, the work our longtime partner conducts is imperative to a better, healthier future. To be recognized as a crucial part to furthering this goal, join this growing team now!

location: King Of Prussia, Pennsylvania
job type: Contract
salary: $28.00 - 28.89 per hour
work hours: 9 to 5
education: Bachelors


responsibilities:
- Ensure all data reviewed is accurate, complete, and compliant with internal procedures and regulatory requirements.

- Participate in audits and inspections as needed, providing accurate and thorough documentation to support compliance efforts.

- Identify opportunities to improve the efficiency and accuracy of the data review process.

- Manage the process of data lifecycle activities, including review, approval, and archiving of laboratory records.

- Communicate effectively with stakeholders to ensure alignment on priorities and timelines.

- Continuously expand knowledge of quality systems, data review tools, and product-specific requirements.

- Regularly update tracking tools or systems to provide visibility into review progress and outstanding items.

- Actively participate in team meetings, providing updates on progress and sharing insights to improve overall performance.

- Ensure all documentation reviewed meets internal and external standards for accuracy, completeness, and clarity.

qualifications:

• Bachelors Degree or 2 years of industry experience - Area of specialization in Biology, Biochemistry, Microbiology or equivalent technical discipline. There is a high volume of data that requires a thorough review using ALCOA principles, attention to detail, meeting turn around times for batch release,
  adhering to procedures, training others and work with minimal supervision.
• Experience with laboratory functionality and technical understanding of
  analytical assays is necessary to execute job functions
• Attention to detail
• Working knowledge of cGXP, Data integrity, ALCOA principles
• System experience preferred- SAP/ERP, LES, Webstatistica, Empower, Hamilton
• Analytical experience preferred (e.g Separations- such as CGE/CE-SDS/HPLC/cIEF,
• Immunoassay- ELISA/qPCR/SPR/Bioassay, Compendia and/or Microbiology-Bioburden/Endotoxin)
• Experience using Excel, Word and Powerpoint
• Strong organizational and task management skills
• Strong leadership skills
• Strong data analysis, data trending and communication skills
• Ability to work independently or as part of a team with minimal supervision

#LI-MH1

skills: Biology, Microbiology, ERP System, High Pressure Liquid Chromatography (HPLC), Enzyme-Linked Immunosorbent Assay (ELISA), Surface Plasmon Resonance (SPR)


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 [email protected].


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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

Any consideration of a background check would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job.