microbiology senior scientist .

job summary:
As a Microbiology Senior Scientist, you will be a member of a dedicated and highly effective quality assurance and control team. You will be responsible for analyzing drug product, drug substance and environmental monitoring microbiological contamination to support our quality programs. Your contribution to environmental testing, bioburden testing, endotoxin testing, microbial identifications, and sterility testing will help provide safe drugs to patients. Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards.

 
location: Sanford, North Carolina
job type: Contract
salary: $54.06 - 70.42 per hour
work hours: 8 to 4
education: Bachelors
 
responsibilities:
- Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

- Analyze and interpret results, makes decisions regarding the accuracy, completeness and compliance.

- Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network.

- Assist Lab leadership in determining scheduling priorities and workload distribution to ensure customer needs are met.

- Perform tasks associated with maintaining current Good Manufacturing Practices compliant Quality Control and Stability laboratories.

- Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.

- Train junior colleagues and develop training plans and oversee training activities for groups.

- Responsible for contributing to and/or handle laboratory investigations for events and Out of Specification results.

- Perform testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.

- Perform laboratory support functions and maintain work area in a neat and orderly manner.

- Write Standard Operating Procedures, technical reports, project plans and other documents independently.

 
qualifications:
Must-Have

- Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associate degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.

- Experience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations.

- Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.

- Understanding of aseptic laboratory techniques and quality systems

- Ability to establish relationships within business lines.

- Excellent effective written and verbal communication and interpersonal skills

Nice-to-Have

- 5 years of experience in Microbiology laboratory analysis

- Experience dealing with Quality Operations and Quality Assurance

- Experience in training other employees in microbial assays.

- Experience in review of Microbiology analysis data

 
skills: Quality Assurance, Microbiology, 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).

Applications accepted on ongoing basis until filled.