Analyst l, QC Analytical 1st-Shift

Job Description

I. JOB SUMMARY

Perform analytical testing per cGMP in support of raw material, in-process, final product, stability. This position will support our First shift operations, working 6am-2:30pm Monday - Friday. Hours may vary to meet business and training needs.

Ii. Essential Functions

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

• Perform WFI sampling and testing as per current protocol, or validation protocols to support the WFI system.
• Perform sampling of raw materials.
• Perform incoming inspection of raw materials and components.
• Clean the laboratory glassware using dishwasher or manually washing, if necessary.
• Perform TOC testing to support release of production equipment.
• Perform daily laboratory tasks, such as balance calibration checks, temperature chart monitoring, CSR duties, etc.
• Maintain the lab equipment and benches in clean and neat fashion.
• Assist with trending, archiving, and maintaining water data.
• Perform various analytical testing procedures as per manufacturing/quality control batch records, stability protocols, raw material requests for testing, etc.
• Participate in calibration, troubleshooting various types of equipment including proactive resolution of instrument issues.
• Write, revise, and review SOP’s and Testing Standards as necessary.
• Review, analyze, interpret and report data.
• Verifies and enters approved results in LIMS or batch records.
• Participate in investigations, CAPA, change control activities and other related studies.
• Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
• Track time worked per project.
• Assist in writing protocols and reports as necessary.
• Inform supervisor upon observing out of specification results.
• Organize final data record and raw material records for review.
• Train and assist lab assistants and chemists as necessary.
• Support department compliance and productivity goals.
• Participation in biomedical screening is required.
  
  

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.

Iii. Minimum Education, Experience, Skills

To perform the job successfully, an individual should demonstrate the following competencies to perform the essential functions of this position.

Education: A minimum of a B.S. in Chemistry or related field

Experience: Minimum of 0-2 years’ experience in a chemistry laboratory or equivalent. GLP/GMP experience is preferred. LIMS or SAP experience is preferred.

Knowledge: College-level knowledge of general chemistry or biochemistry principles, math and writing skills are minimum requirements.

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.

Abilities: 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.

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Compensation Range

$47,077.00 - $70,615.00

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