Assistant Manager, Raw Materials

Caraco Pharmaceutical Laboratories - Greater Detroit Area

Posted 765 days ago
  • Experience
    Mid-Senior level
  • Job function
    Quality Assurance
  • Employment type
    Full-time
  • Industry
    Pharmaceuticals
  • Job ID
    3564487

This is a preview of the Assistant Manager, Raw Materials job at Caraco Pharmaceutical Laboratories. To view the full job listing, join LinkedIn - its free!Join LinkedIn - its free!

About this job

Job description

Purpose:
Responsible for the direction and coordination of quality operations in support of meeting or exceeding cGMP and FDA requirements. Insures accordance with quality, safety standards and all regulatory requirements. Insures compliance of departmental procedures to cGMP’S, and provides training, of employees. Insures timely implementation of testing and in-process monitoring systems to ensure process control and product quality. Typically has one or more supervisors with direct reporting relationship. Typical span of control = 10+ employees.

Essential Duties:
Timely sampling of raw material, receiving raw material into the QC laboratory, all QC/AD/RD outside testing coordination, Mfg COA review, the release of raw materials, addressing raw material FDA deficiencies, and retrieval and distribution of all raw material retain samples.




Job Qualifications:
Core Competencies
Ability ability to motivate others through forward looking practices in the quality field. Knowledge of employee practices and principles, knowledge of state and federal employment laws relating to key areas of responsibility, Analysis and Reporting, Communication and Presentation, Relationship Building, Information and Technology Proficiency, Function, Department and Company Representation, Problem Solving and Decision Making, basic MS Office, intermediate MS Excel, basic Lotus Notes.

Requires knowledge in Chromatography, Dissolution Testing, Spectroscopy, FTIR, and Wet Chemistry.
Above average interpersonal skills
Ability to plan and manage large amounts of testing with high level of quality.
Requires advanced knowledge of computer and lab equipment.
Must have ability to interpret analytical data and document analytical details appropriately.
Hands on experience in HPLC, GC, and UV analysis.
Requires knowledge of analytical method development and validation.
Requires knowledge of ICH, FDA and Regulatory guidelines.
Requires knowledge of compendia requirements
Good written and oral communication including strong technical writing skills.
Above average project management skill.
Must be detail oriented and organized.
Above average record keeping skills and documentation of laboratories testing.
Interpretation and troubleshooting of chromatography.
Advanced level laboratory leadership and operations experience.
Must have ability to effectively work without guidance and direction.
Ability to initiate, perform and oversee OOT/OOS investigations.
Strong multiple priority/multiple task orientation.
Must have ability to interpret analytical data and document analytical details appropriately.

Desired Skills and Experience

Job Qualifications:
Core Competencies
Ability ability to motivate others through forward looking practices in the quality field. Knowledge of employee practices and principles, knowledge of state and federal employment laws relating to key areas of responsibility, Analysis and Reporting, Communication and Presentation, Relationship Building, Information and Technology Proficiency, Function, Department and Company Representation, Problem Solving and Decision Making, basic MS Office, intermediate MS Excel, basic Lotus Notes.

Requires knowledge in Chromatography, Dissolution Testing, Spectroscopy, FTIR, and Wet Chemistry.
Above average interpersonal skills
Ability to plan and manage large amounts of testing with high level of quality.
Requires advanced knowledge of computer and lab equipment.
Must have ability to interpret analytical data and document analytical details appropriately.
Hands on experience in HPLC, GC, and UV analysis.
Requires knowledge of analytical method development and validation.
Requires knowledge of ICH, FDA and Regulatory guidelines.
Requires knowledge of compendia requirements
Good written and oral communication including strong technical writing skills.
Above average project management skill.
Must be detail oriented and organized.
Above average record keeping skills and documentation of laboratories testing.
Interpretation and troubleshooting of chromatography.
Advanced level laboratory leadership and operations experience.
Must have ability to effectively work without guidance and direction.
Ability to initiate, perform and oversee OOT/OOS investigations.
Strong multiple priority/multiple task orientation.
Must have ability to interpret analytical data and document analytical details appropriately.

Work Experience:
Minimum eight years combined experience in various aspects of quality assurance/quality control in pharmaceutical manufacturing.

Education:
Minimum Bachelors Degree in Chemistry or other related biotechnology field.

About this company

Caraco Pharmaceutical Laboratories

Caraco is a growing manufacturer and distributor of generic pharmaceutical products. Caraco is committed to rebuilding it’s manufacturing infrastructure to meet high standards. Caraco is in search of talented individuals who can contribute to our collective success and also interested in the opportunity to enhance their own personal growth. We welcome people that can bring a commitment to excellence and pride to our company.
Click on the "Apply" button now and then please visit Caraco.com to learn more about the company.

Similar jobs

View all jobs like this

This is a preview of the Assistant Manager, Raw Materials job at Caraco Pharmaceutical Laboratories. To view the full job listing, join LinkedIn - its free!Join LinkedIn - its free!

People also viewed