Manufacturing QMS Supervisor

About the role

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.

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

  • 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's degree in Quality Management, Engineering, Manufacturing, or related field (or minimum of 7-10 years of related practical experience in the 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: 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 lift and transport approximately 100-250 lbs. buffer drums on casters with assistance. 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

  • Schedules: 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.
  • 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): 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 | RxVirtual Visits - Aetna/Teladoc Health Savings Accounts (HSA) Flexible Spending Accounts (FSA) Dental Insurance - Aetna Vision Insurance - VSPL 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