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Latitude, Inc. Quality Assurance Specialist I, Quality on the Floor for Packaging 2nd shift in Camden Yards Baltimore, Maryland

Job Description

Title

Quality Assurance Specialist I, Quality on the Floor for Packaging 2nd shift

Department:

Quality Assurance

Site(s):

Camden

Career Ladder:

Scientist

Career Band:

Associate Scientist II

FLSA Status:

Exempt

I: Job Summary (2-4 sentence description of overall job purpose)

The QA Specialist I On the Floor is responsible for assuring the quality of products manufactured at the Baltimore Facility. The QA Specialist I on the Floor will perform Quality on the floor functions. Our QA Department provides expertise in problem-solving and process improvements. The QA Analyst will interact with Packaging personnel and the Quality Engineer to provide the guidance necessary to maintain and improve cGMP compliance at the company.

II: Responsibilities (Include key responsibilities only. This should not be an all encompassing list)

Key Duties will include:

  • Quality at the source utilizing on the floor real time batch record review, disposition and in process auditing.

  • Performance of walkthroughs of GMP areas to ensure inspection readiness of facility is maintained. Includes the documentation, follow up and escalation of observations and areas of concern.

  • QA oversight of manufacturing processes. Provides quality guidance to manufacturing personnel to manage the resolution of in-process deviations.

  • Write and revise Standard Operating Procedures (SOPs).

  • Review and approval of GMP documents such as batch records, engineering runs, work orders, logbooks, and reports to ensure compliance with specifications, regulations, and procedures.

  • Makes recommendation to Quality Assurance Management for the release of a product based on Quality Assurance record review and approval.

  • Actively involved in daily operations to meet schedules and to resolve problems.

  • Demonstrate strong organization skills related to priorities and workload. Ability to solve problems independently and within a team environment.

  • Train and mentor packaging personnel on processes to resolve open issues resulting from record reviews, on the floor walk through activities, and deviation issues.

  • Write, reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, and follow-up plans.

  • Implementation of solutions for identified issues affecting daily manufacturing operations.

  • Represents Quality Assurance to guide the various project and technical meetings, as needed.

  • Support and manage existing and/or develop and implement new programs, processes designed to drive continuous improvement.

  • Review and approval of Standard Operating Procedures (SOPs), and Master Batch Records (MBRs) on eDocs.

  • Supports and Assists Quality Systems on the timely closure of CAPA?s, Gap Analysis and Product Complaints.

  • Track and trend metrics for QA on the Floor audits, Logbook audits and In-Process Audits metrics on a monthly basis for Senior Management.

  • This will be a 2nd shift (2:00 pm to 10:30 pm) Monday thru Friday position. Overtime and weekend work required as needed based on manufacturing needs.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

III: Education, Experience & Skills

BS or BA degree in Science or Engineering with 5-10 years of GMP experience.

  • Must have strong attention to detail.

  • Ability to manage multiple priorities and tasks in a dynamic environment.

  • Excellent written and verbal skills.

  • Ability to exercise judgment to determine appropriate corrective actions.

  • Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.

  • Ability to use computer programs such as eDocs and SAP.

  • Ability to work in a team environment.

  • Proficient knowledge of CGMP.

  • Coordinate multiple tasks simultaneously.

  • Understand and respond to a diverse population.

  • Gowning certification required.

  • Ability to make sound decisions regarding compliance-related issues with moderate supervision.

  • Strong leadership skills; high level of personal/departmental accountability and responsibility.

  • Minimum of one year in an FDA regulated industry.

IV: Physical/Mental Requirements

  • Type/keyboard, stand, walk, sit. Use phone, fax, copier, and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. Most all the time will be spent in the manufacturing rooms where gowning is required.
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