Manufacturing QMS Specialist

Description

Creating a Healthier World through Accessible Biologics:

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSciences Private Limited in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

Position Summary

Under the direction of Manufacturing Management, the Manufacturing QMS Specialist will be executing routine documentation work, which includes writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPA, etc. This position requires technical expertise in upstream and downstream processes of biologics (Cytokines, monoclonal antibodies manufacturing).

Essential Duties & Responsibilities 

• Will be responsible for supporting the manufacturing team with a wide variety of documentation. 
• Documentation includes reviewing executed batch records, logbooks, and other associated documents, both Upstream department and Downstream batch records. 
• Will be responsible for filing change controls, deviations, and CAPAs for the manufacturing department. 
• For all critical/major investigation, will have to use investigation tools like 5why or 6M method.
• Attend daily meetings with both upstream and downstream processes to get all the documentation requirements for the day.
• Will meet weekly with QA to avoid any delay in the QMS closure.
• Will author batch records, SOPs, and associated forms/formats required for the manufacturing process.
• Will be responsible for requesting/submitting all GMP documents to QA.
• During critical campaigns, will support the manufacturing process (shifts)
• Wet lab work will not be more than 10 % of your time. 
• Performs other functions as required or assigned.
• Complies with all company policies and standards.

Requirements

Minimum Qualifications: 

Education:

• A Minimum BA or BS in Biological Sciences or related technical field is required. 
• Minimum 5 years of experience in Biopharmaceuticals. 
• Knowledge of USP and DSP processes

Preferred Qualifications:

Special Skills:

• Previous investigation training
• Ability to work with other team members and independently - good interpersonal skills.
• Good communication skills: verbal and written, good computer and organization skills, detail-oriented.
• Basic computer skills, including knowledge of Word, Excel, and spreadsheets
• Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
• Knowledgeable in cleaning verification/validation. 

Compensation:

• Base Salary Range: $70,000-$100,000 with up to an 8% yearly cash bonus

Benefits/Perks:

• Medical Insurance - Aetna
  • Prescription Drug Converge | Rx
  • Virtual Visits - Aetna/Teladoc
  • Health Savings Accounts (HSA)
  • Flexible Spending Accounts (FSA)
• Dental Insurance - Aetna
• Vision Insurance - VSP
• Life and AD&D Insurance
• Disability Benefits
• Supplemental Benefits
  • Legal Services
  • ID Theft Protection
  • Travel Assistance
• Value Added Benefits & Services
  • Health Advocate
  • Life Assistance Program (LAP)
  • Student Loan Assistance Program
• 401K
• Monthly Cell Phone Allowance

Work Environment & Physical Demands

General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. 

General Work Environment:

• Wear appropriate PPE to work in cleanrooms and/or laboratories that are adequately lit, ventilated, and temperature controlled.
• Desk/computer work (reading, editing, writing documents) required.
• Potential for chemical odor and dust exists.

Standing/Lifting:

• Must be able to move around the facility to reach various equipment.
• Physical lifting and shifting required for pushing and pulling pre-made buffer containers
• Must be able to lift at least 25 lbs. to lift weights onto scale for daily scale verification
• Must be able to stand for long periods of time. Occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching, and walking.

Supervisory Responsibility, if any: N/A

This position description is not a complete list of all responsibilities, duties or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.

Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC comply with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation, and training.