Senior Quality Control Specialist, LIMS - Planet Pharma

615725 Senior Quality Control Specialist, LIMS

Direct Hire

Philadelphia, PA

Shift: M-F, 8am-5pm

Overview

The Senior Quality Control Specialist, LIMS role is responsible for deployment and administration of the QC Laboratory Information Management System (LIMS). This role represents QC in the development, configuration, validation, implementation and maintenance of the LIMS as it relates to QC functionality including analytical and microbiology testing, environmental monitoring, raw materials, critical reagents, stability and sample management to support compliance with regulatory requirements and commitments for clinical and commercial products.

This individual has a good understanding of, and experience with LIMS within a cGMP-regulated environment. The position reports to the Director, Quality Control Compliance.

Essential Functions and Responsibilities

• Understand and execute change management in a GMP environment and drive changes through appropriate quality system. Own changes, as required.
• Support deviations and LIR’s with LIMS information, as needed.
• Collaborate with stakeholders to develop the requirements and the long-term vision for LIMS.
• Drive development and implementation of the LIMS by partnering with IT and external vendors.
• Develop and regularly update key project information such as status, timelines, scope statements, budgets, resources, risks, issues, decisions, and action items.
• Manage enhancements, incident investigation, and changes for a multi-site, global LIMS
• Draft program related support documents including operational SOPs, Work Instructions, System Impact assessments, change controls, as needed.
• Track and resolve LIMS support program issues and identify potential enhancements to the system.
• Independently plan, manage and execute assignments, contribute to project planning meetings.
• Support product stability programs including generation of stability protocols in LIMS, and support as needed accessing final reporting or trending of stability data
• All duties are performed with minimal supervision and oversight
• Must adhere to core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences, computer science or equivalent)
• Minimum of 5-10 years of experience in a cGMP laboratory including at least 3 years as a LIMS administrator. Experience with configuring and implementing a LIMS
• Experience with translating business documents (batch records, test methods, stability protocols) into technical requirements and configuring in a LIMS solution.
• Ability to manage external partners with respect to technical support activities
• Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.
• Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based on changing priorities.
• Problem solver who not only identifies issues but leads efforts to resolve them

Preferred Education, Skills, and Knowledge

• Experience with cell and/or gene therapy products is a plus.
• Experience with MS SQL Server or Oracle database is a plus.

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

Physical Demands and Activities Required:

• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
• Must be able to use near vision to view samples at close range
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.

Mental

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline

Work Environment:

• This position will work in both an office and a manufacturing lab setting.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

We are committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

Pay rate is commensurate with experience. Target pay rate is $120-135K