Description

Your Role:

The Manager, Manufacturing Quality Systems position is responsible for overseeing and coordinating the activities of the Manufacturing Quality Systems (MQS) group. They will collaborate with their team in writing records for Avid's Quality Management System (QMS) including, but not limited to, records for the following: Deviations, out-of-tolerance calibration events, out-of-specification (OOS) results, out-of-limit (OOL) results, and out-of-trend (OOT) results. This role coordinates and participates in investigations required to write these records and routing/tracking records from assignment to approval. Identifies and implements corrective and preventive actions (CAPAs), as applicable. Where issues or improvements are identified, this role works with subject matter experts to propose viable solutions including a final product impact assessment. Identifies and implements solutions for elements that can be made more efficient, are potential sources of discrepancies, require 'fine-tuning', or need a complete revision.

Job Duties:

• Adheres to Good Manufacturing Practice (GMP) regulations (21 CFR, Part 211) and Good Documentation Practices (GDP), as applicable.

• Identifies technical, procedural, and equipment issues that hinder production and compliance, and improves the manufacturing processes.

• Leads and conducts root cause investigations for a variety of events, with reference to related source documents including, but not limited to, procedures, protocols, reports, batch records, laboratory data, and calibration data; apply relevant scientific and technical principles during investigation.

• Write QMS records with excellent attention to detail; ensure records accurately present the facts determined during investigation.

• Coordinates and plans for the implementation of new procedures, processes, and equipment to be used in Manufacturing.

• Designs and conducts small scale studies to support GMP compliance of manufacturing processes and deviation root cause investigations.

• Analyzes process data, writes technical reports and makes technical recommendations/presentations.

• Proactively interface with witnesses and subject matter experts to gather information; interface with Quality Assurance (QA) on questions related, but not limited, to: GMP compliance, Avid procedures and processes, investigation requirements, and record quality and style.

• Manage each record from the time it is assigned through closure; work with all stakeholders to ensure record is closed according to defined timelines.

• Performs specific assignments as requested by VP of Operations.

• Perform other duties as assigned.

Minimum Qualifications:

• Related bachelor's degree (i.e. Biology, Biotechnology, Chemical Engineering)

• 4+ years of cGMP purification experience

• 1+ years of leadership experience or equivalent

Position Type/Expected Hours of Work:
This role is a full-time, exempt position. Days and hours of work are Monday through Friday, 8:00 AM to 5:00 PM unless otherwise stated by Supervisor. The employee must also, if instructed, have the ability to work overtime and/or weekends when necessary.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $116,850 to $138,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.

• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.

• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.

• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.