Specialist II, Quality Operations

The Quality Specialist II, Quality Operations is an individual contributor role responsible for direct interface with clients having the ability to manage are quality related issues. The authoring of deviations classified as Event / Deviations, Minor, Major, and Critical deviations, and associated investigations. Review and approval of production batch records requiring client approvals. Responsibilities may also include but are not limited to management and tracking of deviation and CAPA and Change Control records, support of Quality on the Floor activities, and batch disposition.

Responsibilities

• Quality review of manufacturing batch records.

• Collaborate with the manufacturing teams as needed to reconcile errors on a timely basis.

• Work on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interview.
• Ability to work alone as the single point of contact for client interface meetings representing all Quality activities providing direct support to client ensuring projects are successful and meets client expectations.
• Complete deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.
• Ensuring the written record contains the technical merit and completeness according to regulatory expectations.
• Gathering Data from various sources across the site, support Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, Assessment of event for impact, Identification of Corrective and Preventative Actions to reduce deviation recurrence, performance and leading of Risk Assessments, Causing Mapping, Interviewing.
• Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
• Support the batch disposition process to ensure timely deliverables to the client.
• Participation in the Daily Tier meetings to update leadership on current deviation statuses.
• Must be able to work independently and as a team.
• Ability to adapt to changing priorities and manage multiple assignments while meeting timeline.
• Strong written and verbal communication skills are required. Ability to read and comprehend complex subjects. Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems.
• Expertise in GMP compliance and FDA regulations.
• Demonstrated excellence in technical writing.
• Ability to communicate effectively to key stakeholders.
• Ability to work cross-functionally and to develop and maintain strong business partner relationships.
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Ability to anticipate and mitigate challenges.

Minimum Experience, Education & Qualifications

• Bachelor of Science in relevant studies with related experience.
• Three (3) plus years of related experience in a regulated industry (vaccine, biologics, pharmaceutical)
• Two (2) years of quality or GMP experience within a manufacturing organization

Preferred Qualifications and Ideal Personal Characteristics:

• Experience and knowledge of cGMPs and applicable FDA/EMA regulations in the biotechnology/pharmaceutical industry.
• Experience with Master Control, QAD, and LIMS.
• Experience with using Quality Risk Management principles.
• Experience as a single point of contact for CDMO clients and vendors.

Physical Requirements

Sedentary work.Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

Light work.Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.

Medium work. Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.

This job requires the employee to perform the following physical activities:
Climbing
Balancing
Fingering
Stooping
Kneeling
Repetitive motion
Crouching
Crawling
Feeling
Reaching
Standing
Grasping
Walking
Pushing
Hearing
Pulling
Lifting
Talking

This job requires the employee to perform the following type of physical work:
Temperature changes
Activities occur inside and outside

This job requires the following visual activity requirements:
preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
determines the accuracy, neatness, and thoroughness of the work assigned (i.e., custodial, food services, general laborer, etc.) or to make general observations of facilities or structures (i.e., security guard, inspection, etc.).

This job requires exposure to the following:
Noise (enough noise to cause the employee to shout to be heard above ambient noise level.)
Hazards: moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
Hazards: packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
Narrow aisles or passageways.