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Manager, QC Sample Management & Stability Full-time

at LSNE Contract Manufacturing in New Hampshire (Published at 12-02-2019)

JOB SUMMARY - To support our rapid growth, we are seeking a highly talented and motivated Manager, Quality Control (QC) Stability and Sample Management to join our organization. The Manager, QC Sample Management and Stability will be responsible for the oversight and management of all day to day activities in support of the sample management and stability programs for Quality Control. This role will require a high level of customer service, collaboration and cross functional support for manufacturing operations at our Harvey, Commerce and Sundial Facilities, including interactions with external customers. The ideal candidate will be an innovative leader with experience in fast-paced Quality Control testing environments.

JOB DUTIES

General:

  • Actively partners with Project management, Operations, Materials management and Quality Assurance to ensure completion of activities within required timelines are met.
  • Author(s) and revise(s) technical documentation (e.g. SOPs, policies, forms, etc.) as required.
  • Manages a team of 2-4 direct reports.
  • Perform continuous improvement for areas of responsibility, collaborating other departments to identify and implement process efficiencies.
  • Other activities as assigned.

Sample Management:

  • Responsible for the management of QC test samples including receipt, storage, and distribution of samples to internal and external testing labs in accordance with required turnaround times.
  • Responsible for the management and long-term storage of retains and reference standard samples.
  • Maintains sample tracking and chain of custody records in accordance with cGMP and procedural requirements.
  • Requests, assembles, and distributes QC testing data packets for support of in-process, lot release and stability testing.
  • Maintains Quality Control testing source data packets and performs data archival as required.
  • Requests and maintains Quality Control logbooks in accordance with cGMP and procedural requirements.
  • Responsible for inventory management of all QC laboratory supplies including reagents, media, consumables, etc.
  • Ensures that materials are appropriately labelled and stored per procedural requirements.Ensures that obsoleted and expired samples and materials are disposed of in accordance with procedural requirements.
  • Monitors QC equipment and coordinates required activities with support group(s) to ensure all laboratory equipment is maintained in an operational state.
  • Responsible for performance of all QC equipment maintenance tasks.
  • Maintains QC laboratory instrumentation and supporting documentation in accordance with cGMP and procedural requirements.
  • Responds to QC equipment alarms and ensures appropriate resolution.
  • Contributes to investigations and deviations related to QC sample management.

Stability:

  • Design, implement and manage phase appropriate GMP/ICH compliant stability program(s) including stability protocol planning, writing, set-up (sample distribution internal and external), review, management of data (trending), completion of stability reports, change controls and regulatory submissions.
  • Support all outsourced stability testing including method development, feasibility, qualification, transfer, test results and timely reporting of results.
  • Provide technical expertise, trouble shooting and assay development to support internal quality control testing.
  • Contribute(s) to impact assessment of temperature/humidity excursions, Out of Trend (OOT) and Out of Specification (OOS) investigations for stability testing.
  • Ensures completion and timely delivery of stability results
  • Reviews generated records and reports ensuring generated data is accurate, valid and complete.
  • Maintains knowledge of current regulatory requirements and standards as they pertain to the Stability and QC departments; Serves as a stability subject matter expert (SME), as needed in regulatory audits; Evaluates and continuously improves stability systems, quality and compliance with regulatory requirements, best practices and quality systems procedures

Raw Materials:

  • Responsible for QC inspection, sampling and testing coordination of incoming components and raw materials, including chemicals, biologicals and packaging / labeling materials in accordance with CGMP and procedural requirements.
  • Responsible for authoring and revision of raw material specifications as required.

PROFESSIONAL SKILLS

  • Excellent communication skills both written and verbal.
  • Effective time management, multitasking and organizational skills with the capability to manage multiple priorities at once.
  • Strong attention to detail and cross functional team experience.
  • Proven team and people leader and able to drive team building and individual professional development
  • Ability to work independently and in compliance with cGMPs.

EXPERIENCE

  • Minimum of 6 years of experience in the biotechnology or pharma industry with a primary focus on stability and sample management for regulated products
  • Experience with testing and/or management of stability testing programs strongly preferred.
  • Established background in analytical development and/or technical QC GMP experience.
  • Experience with vendor management of CMOs and/or CTLs is preferred.
  • Expertise in ICH guidelines, USP/EP for raw material and stability testing of pharmaceutical products
  • Proficiency with computer systems such as Microsoft Office applications and data trending programs (e.g. jmp)

EDUCATION

  • Bachelor of Science degree in Biological Sciences, Bioengineering or Chemistry

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

  • Minimal physical effort is normally required
  • Work is mostly sedentary but does require walking, standing, bending, reaching, climbing stairs, lifting or carrying objects that typically weigh less than 50 lbs.

COMMUNICATIONS & CONTACTS

  • Interacts with all departmental staff to coordinate activities

MANAGERIAL & SUPERVISORY RESPONSIBILITIES

  • Manages and develops direct reports.
  • Assigns responsibilities and duties within the group
  • Provides constructive feedback to team and authors performance reviews within corporate timelines

TRAVEL

  • Must be able to walk and/or drive between NH locations
  • Some domestic travel may be required,

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

We are a fast growing, dynamic contract manufacturing privately held company specializing in process development, lyophilization and fill/finish located right in Southern NH.

We are always on the lookout for outstanding individuals, recent graduates, talented professionals, and experienced leaders with a strong work ethic, creative spirit and positive attitude.

We offer a competitive compensation and benefits package and a very generous paid time off benefit. Join our team!



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