Careers

Manufacturing Compliance Specialist

Job Description

The Manufacturing Compliance Specialist is responsible for the investigation and completion of process deviations aimed at identification of root cause, and implementation of correct actions to prevent recurrence. Compliance specialists are expected to work in a cGMP environment, have working knowledge of biological manufacturing processes, the ability to manage multiple ongoing projects concurrently, have strong meeting facilitation and conflict resolution skills, a strong technical writing capability, be action oriented, and be compliant minded while performing investigations.

Essential Duties and Responsibilities

This position requires working under the 21 CFR part 210 /211 standard pharmaceutical cGxP quality
system processes.

The key duties and responsibilities for this position are as follows:

  • Perform root cause analysis on manufacturing deviations, serving as primary author of deviation reports, utilize technical writing for the educated but uninformed reader, translate moderate to complex scientific events into a brief and cohesive report as a finished product. Address comments from both internal and external stakeholders on the final report.
  • Lead investigations for manufacturing and bring them to a resolution with minimal direct supervision. Gather Data from various sources across the site, perform of Root Cause Analysis to determine the most likely cause of the deviation investigation, Assessment of event for impact to SISQP, Perform Trending Analysis, Identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, and Causing Mapping facilitation.
  • Initiate appropriate corrective action/preventative action (CAPA) to prevent deviation recurrence. Work closely with manufacturing operations, QA team, and support groups to develop appropriate CAPAs.
  • Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward. Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objective.
  • Management of multiple projects and timelines concurrently. Ability to adhere to standard timelines and escalate actions appropriately for resolution in a timely manner. Participation in the Daily Management meetings to update leadership on current deviation statuses.
  • Work with the manufacturing team by going to the production areas for data gathering, observing of processes for investigations, and performance of associate interviews.
  • Follow and adhere to all given instructions including work procedures, Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).
  • Strictly adhere and observe all safety policies as outlined in the company policies and training sessions.

Knowledge, Skills & Abilities:

  • Prior experience technical writing and in a manufacturing, environment preferred.
  • Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure. Must work well on a team and be able to trouble shoot and problem solve in a cross functional team setting. Must be proactive, action oriented, and can adapt to change. Must be able to identify and flag risks in a timely manner to keep deliverables on track.
  • 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.
  • Ability to understand and apply GMP regulations as they relate to manufacturing.

*This job description is not designed to cover or contain a comprehensive listing of duties, activities, or responsibilities that are required of the employee. Other duties responsibilities, and activities may change or be assigned at any time with or without notice.

Desired Qualifications and Requirements

Education and Experience Required:

  • Knowledge of relevant cGMP, ISO 9001, and ICH requirements for document control and quality records
  • Minimum of 4+ years' experience conducting investigation and root cause analysis in a pharmaceutical or FDA/GMP environment required
  • Experience with GMP compliance in clinical/commercial manufacturing environment required
  • Experience with quality management software (Mastercontrol, Trackwise, etc.) preferred
  • Experience with asset management software (Blue Mountain, Maximo, etc.) preferred

The successful candidate will have the following attributes:

  • Well-organized and detail-oriented with strong technical skills, excellent written and verbal communication skills, and proven ability to multitask
  • Strong interpersonal skills and the ability to effectively collaborate with others in a dynamic team environment
  • Capable of supporting multiple projects simultaneously in a deadline-driven environment
  • Adaptability, flexibility, independence, and resourcefulness to thrive in a fast-paced, small-company environment
  • High level of proficiency in Microsoft Word, Excel, and SharePoint
  • High integrity and ethics
  • Commitment to quality and timely delivery of results

Physical Requirements:

  • Sit for extended periods of time (2 or more hours)
  • Standing for extended periods of time (2 or more hours)
  • Occasionally lift or carry up to 20 kg

Application Instructions:

Please submit a resume and cover letter to jobs@lumen.bio with the job title in the subject line.

This position is available immediately. Applications will be reviewed upon receipt. Only successful applicants will be contacted.