We are seeking a Specialist Quality Control for testing & development in areas of molecular biology and microbiology.
Doctorate degree or master’s degree in Sciences and 3 years of directly related experience or bachelor’s degree in Sciences and 5 years of directly related experience.
- Responsible for providing technical guidance, provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
- Resolve technical issues and troubleshoot for assays, as necessary.
- Ensure lab compliance – which includes implementing procedures that enhance GMP, GLP and safety.
- Manage existing and/or develop and implement new programs, processes, and methodologies.
- Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
- Approve lab investigations,
- Lead audit teams
- May serve as subject matter expert to develop technical training.
- May perform routine work in a specific area of responsibility, as necessary.
- Represents the department/organization on various teams,
- Independently responsible for following through on multi-site action items.
- May interact with regulatory agencies regarding area(s) of responsibility including written responses.
- May resolve issues with outside resources.
- Performs special projects as requested by supervisor,
- May supervise employees as necessary to meet technical requirements.
Ultimate Solutions Corp is an Equal Opportunity Employer.
- Excellent communication skills, facilitation, and presentation skills.
- Excellent technical writing skills.
- Strong computer operation skills including work processing, presentation, database, and spreadsheet application skills,
- Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions, and follow assignments through to completion.
- Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
- Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
- Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.
- Knowledge of pharmaceutical processes,
- Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.
- Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.
- Extensive knowledge and application of GMPs/CFRs.
- Ability to evaluate compliance issues.
- Skill in evaluating and documenting according to Company and various guidelines.
- Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.
- Advanced scientific data analysis and interpretation skills.
- Advanced skills in solving complex problems.
- Advanced data trending and evaluation.
- Strong skill in working independently and to effectively interact with various levels.
- Ability to interact with regulatory agencies both orally and in writing. Initiate, coordinate and lead cross functional teams.
- Excellent skill in leading, motivating, influencing, and negotiating.