Working within the Operations Department in the formulation of diagnostic products and reagents. You will be required to analyze procedures and formulation methods to improve quality, costs or productivity, in keeping with product specifications, good manufacturing practices, Federal safety regulations and Company policies
- Manufactures routine to advanced reagents, controls, buffers, calibrators, antibodies, conjugate purifications and micro concentrates, using cGMPs.
- Manufactures other products as appropriate
- Handles and mixes chemicals using analytical balances and other analytical instruments. Transfers contents of mixing tank to batch tank, mixes, samples and either filters or ozonates product as specified by DHR and pertinent SOP’s.
- Performs analytical and functional testing of products.
- Perform initial review on departmental paperwork; completed batch records
- Maintains and analyzes lot histories for trends and discrepancies
- Maintain and order lab supplies
- May write, review, and modify SOPs, work instructions and reports.
- Initiate NCARs
- Maintains, troubleshoots equipment as appropriate
- May train and mentor new Associate Technicians
- May need to work with small animals
- May need to work with aseptic technique
- Keeps department lead or supervisors updated on all issues.
- Assist the Chemist or Supervisor with other assigned projects or assignments.
- May be required to operated a pallet jack.
- Participates in PPI, Lean, and 5-S programs.
- BS/BA in scientific discipline (i.e. chemistry/biochemistry) with 0-3 years related experience and/or training preferred.
- Equivalent combination of education and years of related experience may be substituted. Basic lab skills and knowledge of safety precautions.
- Must have excellent math and communication skills and working knowledge of the metric system (weights & volumes).
- Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations
- Proven problem solving skills.
- Demonstrated ability to organize and prioritize work.
- Working knowledge of computer applications (including word processing & spreadsheets).
- Ability to work effectively with team members at all levels.
- Ability to follow written and oral instructions.
- Demonstrated good safety and quality practices.
- Familiarity with Quality System Regulations: o Knowledge of GMP, FDA, ISO Regulations for diagnostics manufacturing
- Experienced in working with potentially hazardous chemicals and human source materials.
- Demonstrate Thermo Fisher Scientific values – Integrity, Intensity, Innovation and Involvement
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle or feel objects, tools, or controls; talk and hear; and smell.
- The employee frequently is required to reach with hands and arms and stoop, kneel, crouch, or crawl.
- The employee is occasionally required to sit.
- The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
- Vision abilities required by this job include close vision, distance vision, color vision, and the ability to adjust focus.
Thermo Fisher Scientific - 12 months ago
Whether for research, analysis, discovery, or diagnostics, Thermo Fisher Scientific gets the laboratory ready to assist mankind. Created...