Quality Assurance Specialist, GMP Operational Quality (v238)

  • Contract Duration: 6 months, possible extension
  • Manufacturing
  • Boston, MA

Website Lenox Executive Search

Description

Lenox Executive Search is seeking a Quality Assurance Specialist for a contract role with one of our global pharmaceutical clients, working in Boston, MA. This is a 6 month contract role with the possibility of extension and/ or conversion. Experience with MATERIAL AND BATCH RELEASE ARE A MUST!!

REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES of a Quality Assurance Specialist:

Key Leadership Skills

  • Cross- functional collaborator
  • Results Driver

Key Knowledge/ Skills and Competencies

  • Ability to perform functions independently in accordance with cGMP guidelines.
  • Strong written and oral communication skills required
  • Good interpersonal skills required
  • Ability to work effectively and meet challenging timelines in a fast –paced and high throughput environment
  • Strong organizational skills, work ethics and respect for all customers.
  • Ability to independently coordinate with cross-functional teams
  • Ability to think strategically and tactically, balancing these as workload changes.
  • Attention to detail
  • Expert knowledge of global GMP requirements governing oral drug products and knowledge of oral drug product manufacturing practices
  • Proven experience supporting GMP manufacturing either via experience in manufacturing and /or process development or experience providing QA operational support of GMP manufacturing as a QA reviewer working with Batch Records or in QC Analytical role

KEY RESPONSIBILITIES of a Quality Assurance Specialist:

  • As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to operations at the Company in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and materials management

Product Release – Internal Manufacturing

  • Responsible for reviewing batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
  • Responsible for dispositioned product labelling and coordinating with Materials Management to support product shipment.
  • Responsible for archival of batch records and other supporting documents in QDoCCs

Compliance Oversight of Internal Operations and Quality Systems

  • Provide production floor support and guidance on any manufacturing related issues for GMP Continuous and non-continuous product manufacturing.
  • Review and approval of Manufacturing documents (as required)
  • Responsible for raw material release, area clearance, line clearance and equipment release
  • Provide QA support of change controls, GMP investigations and CAPAs (as required). Responsible for updating QA database to support generating performance metrics, trends.
  • Participate in compliance walkthroughs and help drive the closure of any observations
  • Responsible for identifying risks and communicating gaps for GMP process/systems
  • Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
  • Participate in inspection readiness and support activities (as necessary)
  • Participate in process improvement initiatives (as necessary).
  • Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner

REQUIRED EDUCATION AND EXPERIENCE of a Quality Assurance Specialist:

  • Experience providing QA support and oversight of GMP manufacturing operation including batch release.
  • Experience providing QA support and oversight of Material Management operations including incoming material release.
  • Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
  • cGMP’s and associated CMC regulatory considerations
  • experience with continuous manufacturing a plus
  • Experience with network based applications such as Oracle, VeeQMS
  • Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 3 years of relevant work experience, or relevant comparable background.
Upload your resume here.

Our COVID-19 Policy

As with other larger employers and customer-facing organizations, Lenox Executive Search is carefully monitoring the situation regarding Coronavirus (COVID-19), with a particular focus on public health guidance offered by the CDC and state officials.  We are reaching out to make you aware of our activities and preparations in light of the spread of the Coronavirus (COVID-19). Our number one priority is the safety of our employees, clients and the broader community. Given the current unpredictable nature of the spread of COVID-19, and in an abundance of caution, Lenox Executive Search has implemented the following practices immediately:
  • We have increased our overnight cleaning activities to ensure frequently touched areas are being disinfected and sanitized.
  • We have implemented social distancing techniques to minimize the typical face-to-face- contact by utilizing teleconference calls and flexible workspaces.  We have suspended non-essential business travel for our employees and have asked that inter-company meetings be conducted via teleconference. In addition, we kindly ask all of our customers to help us maintain a handshake-free zone at all Lenox Executive Search locations.
  • We have asked employers who feel ill to stay home.
  • We have convened a team of senior leaders who meet daily to discuss the situation and stand ready to take additional steps, if necessary.
  • We have measures in place to ensure our operations can effectively continue so that we can provide our clients uninterrupted service.  Lenox Executive Search already had robust and detailed business continuity plans in place.
– The Lenox Executive Search Team