Supervisor, QC Analytical-3rd Shift-Baltimore

Bora Pharmaceuticals; Baltimore (MD); On-site; USD 75,000 - 114,000; Full time

Job summary

Bora Pharmaceuticals is seeking a Supervisor for the QC Analytical-3rd Shift team in Baltimore. The role involves overseeing laboratory activities, ensuring compliance with cGMP standards, and managing testing processes for raw materials and finished products. Candidates must have a B.S. in Chemistry and substantial experience in a lab setting, particularly with HPLC and GC instrumentation. This is a full-time position with typical hours from 10:30 PM to 7:00 AM, Monday through Friday.

Qualifications

• Minimum of 5 years of experience in a chemistry laboratory or equivalent.
• Extensive technical expertise in analytical instrumentation in the Pharmaceutical industry.
• Must be able to proficiently apply knowledge to new and existing testing applications.

Responsibilities

• Supervises the QC Laboratory (Analytical) Services group.
• Reviews testing data and batch records for accuracy and completeness.
• Ensures on-time delivery of testing and key performance metrics.

Skills

Analytical testing

Technical expertise in instrumentation

Regulatory compliance knowledge

Communication skills

Education

B.S. in Chemistry or related field

Tools

HPLC

GC

LIMS

Excel

Word

Job description

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Job Summary

Responsible for maintaining a safe and professional work environment supporting raw material, component, in-process, final product and stability testing. Ensures on-time delivery of testing and key performance metrics for the second shift. Perform analytical testing per cGMP as needed to support shift operations. This position will support our 3rd -shift operations. Typical hours are 10:30pm – 7:00am, Monday through Friday. Hours may vary to meet business and training needs and may include weekend work.

Job Summary

Responsible for maintaining a safe and professional work environment supporting raw material, component, in-process, final product and stability testing. Ensures on-time delivery of testing and key performance metrics for the second shift. Perform analytical testing per cGMP as needed to support shift operations. This position will support our 3rd -shift operations. Typical hours are 10:30pm – 7:00am, Monday through Friday. Hours may vary to meet business and training needs and may include weekend work.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Supervises the QC Laboratory (Analytical) Services group in support of production by ensuring the timely release of manufacturing equipment, the water for injection system, raw materials, in-process and finished products.
• Reviews testing data and batch records (RM, FP, Stability, etc.) for accuracy and completeness and coordinates their timely completion.
• Assists Analytical Services Manager in defining the activities of the Analytical Services laboratory to assure that all the test samples meet the raw materials, in-process and final products, and stability specifications.
• Serves as a resource of technical knowledge for established assays.
• Maintains schedules for analytical testing and stability testing that support corporate manufacturing schedules.
• Organize and oversee equipment release for production support.
• Assist Analytical Services Manager with all day-to-day production issues as they arise.
• Oversee CGMP work in lab, including, but not limited to stability testing, in-process and finished product testing.
• Ensure that all laboratory equipment, such as HPLC’s, UV’s, GC etc., are fully calibrated and validated.
• Assist all analytical personnel with troubleshooting, etc.
• Coordinate with other Departments such as Formulation, Production, Project Management, and QA to maintain corporate schedules.
• Assist in reviewing QC Batch Records before submission to QA.
• Write and review SOPs and Testing Standards as necessary
• Assist in writing protocols, reports, etc. as necessary.
• Inform Manager upon observing out of specification results.
• Leads investigations for in-process and finished product, stability, or other CGMP data.
• Trend deviation and OOS investigations and batch record turn around.
• Assist with managing CAPA system.
  
  

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Education

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• A minimum of a B.S. in Chemistry or related field.
• College and industry-level knowledge of general chemistry or biochemistry principles, math and writing skills are minimum requirements.
• Extensive technical expertise in analytical (chemistry) instrumentation and methods, including HPLC and GC in the Pharmaceutical industry.
• Must be able to proficiently apply knowledge to new and existing testing applications.
• Knowledgeable and resourceful with regulatory expectations, guidance and resources.
  
  

Experience

• Minimum of 5 years of experience in a chemistry laboratory or equivalent.
• GLP/GMP experience is preferred. Empower, LIMS or SAP experience is preferred.
• Method development, improvement, or validation experience and chromatographic/biochemistry testing experience is preferred.
  
  

Skills

• Can perform at an intermediate level of Excel and Word. Must possess knowledge of table building in Excel and formatting in Word.
• Must be able to write legibly and accurately and contemporaneously record work in written and/or electronic form.
• Effective verbal and/or written communication, the ability to complete daily tasks as assigned, the ability to improve processes, the ability to work independently and in a group, the ability to multi-task, and the ability to train on and learn computer-based programs and systems.
• Proven demonstration of qualifications related to Excel, Word, LIMS, or SAP systems is preferred, including course work.
  
  

Compensation Range

$75,789.00 - $113,684.00

Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals Injectables, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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