Quality Assurance Specialist Document Control

ABOUT US

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!

JOB SUMMARY

 The Quality Assurance Specialist will support the day-to-day cGMP documentation management activities, including but not limited to review of documents under revision, issuance of records, tracking of controlled documents, and management of the Quality Files. He/She will collaborate cross-functionally with Manufacturing, Supply Chain, Facilities, Process and Analytical Development, and customers to ensure cGMP compliance. This highly motivated member of the Quality Unit will assist in promoting a culture of compliance throughout the organization through driving document control processes.

ESSENTIAL JOB FUNCTIONS

 · Support cGMP manufacturing operations through issuance of records and lot number assignment

· Using the EDMS, review document change requests for completeness, consistency, and compliance. Ensure documents comply with formatting guidelines prior to routing for final approval. Review references and ensure impacted documents are addressed.

· Communicate with all relevant stakeholders to understand the documentation needs and the timeline/need-by dates.

· Follow-up with reviewers throughout the review process to ensure documents are approved within the timeframes needed and that all feedback is addressed quickly and appropriately.

· Assist colleagues' company-wide with understanding and adopting document control and records management practices in alignment with established procedures.

· Manage document control room, including record requests and archiving activities.

· Support the continuous improvement initiatives and oversight of Quality Management System procedures.

· Participate in internal and external audits in accordance with internal procedures for audit and inspection management.

· Actively participates in fostering a positive, collaborative work culture.

Experience and Skills

 EDUCATION AND/ OR EXPERIENCE

· BS preferred in a scientific/technical discipline with 2+ years of experience within the biological and/or pharmaceutical industry.

· Document management/control experience

· 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, customers and vendors

· Strong organizational skills; able to prioritize and manage through complex processes/projects

· Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.

· Prior experience working in a cGMP environment is strongly preferred

· Detail-oriented and highly motivated with excellent written and verbal communication skills required.

· Involvement in continuous improvement initiatives

· Ability to work independently and stay on task in a fast-paced environment without direct supervision.

· Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.

· Very proficient in MS Office application suite as well GMP electronic applications such as LIMS

PHYSICAL DEMANDS

• Bending, standing, walking, lifting, sitting, carrying, repetitive motions typing- filing – writing,

• This role is based in Watertown, MA

BENEFITS

• Phone reimbursement policy for qualified individuals
• Free parking
• Highly competitive healthcare with many plan options:

• Medical (HMO/PPO/EPO)
• Dental
• vision

• 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)