Arranta Bio QA Specialist I-III in Watertown, Massachusetts
Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio’s mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product.
WHO ARE WE
Arranta hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.
Here at Arranta Bio, we embrace ALIVE – our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.
We embrace our challenges as opportunities.
We are empowered to think and act.
We never settle; we strive to improve through purposeful creativity.
We build aligned teams who learn, grow, and deliver.
We are committed to building strong relationships.
Are you ready to come ALIVE with a daring and intrepid team? Don’t wait another minute; Apply today!
The Quality Assurance Specialist will support the day-to-day GMP manufacturing operation via execution of all operational elements of the Quality Management System (QMS), including but not limited to deviations, corrective and preventive actions (CAPAs), investigations, excursions, out of specifications (OOS), change control, batch review and disposition, and training in support of biologics manufacturing production. He/She will collaborate cross-functionally with Manufacturing, Supply Chain, Facilities, Process and Analytical Development and clients to ensure cGMP compliance and establish a quality culture. This is a unique opportunity to help build and grow the QA Operations organization in a dynamic and fast-paced CDMO environment.
ESSENTIAL JOB FUNCTIONS
· Support cGMP manufacturing operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
· Review and approve batch records.
· Perform the review and approval of commissioning and qualification documentation for facilities, equipment, and utilities.
· Review and approve preventative maintenance, calibration, and work order documentation.
· Review, assist in the investigation of, and approve environmental excursions.
· Provide on-the-floor QA support for manufacturing activities.
· Represent Quality Assurance on project teams and in meetings.
· Support the continuous improvement and oversight of Quality Management System procedures.
EDUCATION AND/ OR EXPERIENCE
· BS required, MS preferred in a scientific/technical discipline with 10+ years of experience in a QA position within the biological and/or pharmaceutical industry.
· Ability to apply GMP regulations and international guidelines to all aspects of the position
· Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
· Exceptional oral and written communication skills to all organization levels as well as clients and vendors
· Strong organizational skills; able to prioritize and manage through complex processes/projects
· Extensive experience with writing and managing investigations and risk assessments
· Ability to write reports, business correspondence and SOPs
· Ability to be hands-on and detail orientated
· Very proficient in MS Office application suite as well GMP electronic applications such as LIMS
• Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
• Bending, standing, walking, lifting, sitting, carrying, repetitive motions typing- filing – writing,
• This role is based in Watertown, MA
Keyword: Quality Assurance
Phone reimbursement policy for qualified individuals
Highly competitive healthcare with many plan options:
Flexible Spending Accounts for medical expenses and dependent care expenses
Up to 10 weeks of 100% paid maternity leave
2 weeks of 100% paid paternity, domestic partner, & adoption leave
Educational assistance program
401k (traditional and Roth offered) with 100% match on first 5% deferred.
A suite of Arranta Bio paid insurance coverage, including life insurance, short-term and long-term disability
Voluntary legal assistance plan
Employee Referral program
Competitive PTO plan, in addition to 10 company paid holidays (includes 2 floating holidays)
From: Arranta Bio