Manufacturing QMS Supervisor

Description

Company Overview

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

The Manufacturing QMS Supervisor position is responsible for Process Improvements (deviation investigations, change controls, CAPA’s), Documentation Control (generate, review, and update SOPs, batch records, and quality manuals), Audit and Compliance reviews, and Cross-Functional Support (train staff on quality policies, adherence to current Good Manufacturing Practice (cGMP), and collaboration with supporting groups for resolution of issues) within a mammalian cell-based cultures and producing recombinant proteins manufacturing facility for a wide range of mammalian based biosimilars. 

The candidate will be responsible for setting clear standards and goals for product quality, supervising deviation investigations, non-conformities, change controls, CAPA’s, SOPs, batch records, and quality manuals. 

Essential Duties & Responsibilities

• Provide supervision for the QMS process at multiple scales for a cGMP environment.
• Provide technical oversight and direction in the execution of QMS related processes. 
• Prepare / review all quality management related documents (Deviation / Change control / investigation reports etc.)
• Routine review of in-process batch records for timely closure. 
• Lead audit review, manage corrective and preventative actions (CAPA), support internal audits, and support external regulatory inspections. 
• Use various programs to collect and evaluate operating data to conduct sound information for relevant documentation. 
• Analyze quality data and metrics to identify operational trends, root cause, and areas for continuous improvement.
• Audit and Compliance review to ensure staff are trained in quality policies and adhere to current Good Manufacturing Practice (cGMP).
• Cross-Functional Collaboration with supporting groups and vendors to resolve technical issues.
• Works with other teams and outside vendors to resolve technical issues as well as maintenance of production equipment.
• Adhere to all cGMP instructions in the manufacturing area and lead by example by following environmental health and safety policies.
• Comply with all company policies and standards.

Requirements

Position Requirements and Qualifications

Minimum Qualifications: 

• 3 to 5 plus years working in Quality Assurance, Quality Control, or QMS administration. 
• Minimum of 2 plus years in a leadership or supervisory role.

Education

• Requires a Bachelor or Master’ degree in Quality Management, Engineering, Manufacturing, or related field (or minimum of 7-10 years of related practical experience biopharmaceutical industry.

Preferred Qualifications:

• Previous experience working in GMP and aseptic manufacturing environment.
• Experience working with related manufacturing equipment and/or disposable technologies. 
• Ability to work with other team members and independently - good interpersonal skills.
• Good communication / documentation skills: verbal and written, good computer and organization skills, detail oriented.
• Basic computer skills, including knowledge of Word, Excel and spread sheet.
• Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
• Possess knowledge or familiarity with GMP documentation.
• Knowledgeable in cleaning verification/validation. 
• Strong familiarity with industry standards and document control workflows. 

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:

• Majority of work involves desk / computer work (reading, editing, writing documents).
• Wear appropriate PPE to work in cleanrooms and/or laboratories that are adequately lit, ventilated, and temperature controlled.
• 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.
• Frequent lifting/moving of approximately 25-50 lbs.
• Frequent transporting of approximately 100-250 lbs. buffer drums on casters with assistance.
• Frequent repetitive motion.

Additional Position Information:  

• As a biologics/biosimilars company, our schedules are driven by process requirements. 
• Manufacturing Operations is 12hr shifts for 24/7 coverage (2-2-3 work schedule), including holidays and weekends. Shift A (day shift): 7:00 AM to 7:00 PM EST and Shift B (night shift): 7:00 PM to 7:00 AM EST. 
• o Initial training may be performed on the day shift
• Required Overtime (time-and-a-half pay), holidays, and weekends. 
• During the interview process, please let us know whether you have a preference for the day shift, the night shift, or are open to both.
• Compensation: These are hourly FTE positions with overtime eligibility and shift differentials for applicable evenings.
• Manufacturing QMS Supervisor (7 to 10 plus years of biologics manufacturing experience): 
• o Base Salary Range and Yearly Bonus - $80,000 to $110,000 (dependent on years of experience and fit for the position) with up to a yearly (discretionary) cash bonus
• Kashiv BioSciences can provide sponsorship support for qualified candidates. Please let us know if you currently require sponsorship or may require sponsorship in the future.
• Interviews and employment are conducted onsite at our Piscataway, NJ facility. Candidates should currently reside within a reasonable commuting distance or plan to relocate to the area.

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

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.