Manufacturing QMS Specialist

The Manufacturing QMS (Quality Management System) 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.

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

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.

Work Environment & Physical Demands

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.