QC Microbiology Associate (TEMPORARY)

Skills

• Continuously looking internally and externally for best practices and areas for improvement.
• Provides clear instruction and direction to team members to assure fast action and effective completion of technical, laboratory and/or compliance related projects.
• Leads by example with thorough, effective laboratory work and decision making that helps to motivate and inspire the team to broaden their knowledge base and elevate performance.
• Understands patient and customer needs and builds relationships as required to meet department objectives.

EXPERIENCE

1. Detailed knowledge of quality management systems, current Good Manufacturing Practices, longstanding expertise and practice with QC principles.
2. Ability to deliver all ideas and work with a compliance mindset and alignment with pharmacopeia regulations and international guidance documents.
3. Demonstrated working knowledge and critical thinking with respect to certified functional activities, with subject matter expertise on several technical modules or quality management systems.
4. Excellent documentation, written and verbal communication skills are essential.
5. Must possess the ability to perform routine and non-routine tasks under minimal supervision while modeling initiative, self-direction, objectivity and team advocacy.
6. Ability and willingness to provide input to the entire group, with proficiency in both facilitating active and open discussion and laying groundwork for logical decision making.
7. Working knowledge of cGMP regulations pertaining to test result disposition, stability protocol generation and execution and critical reagent program management, is desired.
8. Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, Project and/or Visio is desired.
9. Expertise with laboratory software functions, such as within MODA or LIMS, is optimal.
10. Fluency with experimental design and data trend / comparability evaluation per statistical models, with some advanced software experience such as with JMP or Power Pivot.
11. Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.

Education

B.S. degree, or equivalent, in a biological or biochemical science and at least 5 years of experience in a pharmaceutical laboratory, with at least 2 years as part of a QC organization

PREFERRED QUALIFICATIONS

Candidate must be a motivated employee capable of working in a fast-paced environment to produce quality and timely results. Strong time management and organizational skills. Experience managing projects and processes. Strong people skills. Experience with meeting organization and facilitation. Practiced in technical training element and program deployment. Ability to foster a team-oriented environment. Experience authoring and reviewing SOPs, test records, work instructions, OJTs, and other controlled documents.

In the U.S, the  temporary worker pay for this position is *31* to *50* per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors.