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Senior Quality Analyst

2 months ago

Wilson, United States The Rockridge Group Full time
Job DescriptionJob Description

TITLE: SENIOR QUALITY SPECIALIST II

Job Summary:

The Sr. Quality Specialist II is a first shift position that reports to the Associate Director, Quality and is primarily responsible for authoring GxP deviations and CAPAs. The role also provides support for change control activities and back up for certain MQA activities.

Primary Responsibilities:

  • Utilize root cause analysis tools to drive to root cause of GxP deviations. Complete impact analysis and identify appropriate corrective actions to prevent recurrence.
  • Collaborates with SMEs from other departments while hosting SME team meetings to ensure a cross functional evaluation is completed.
  • Oversee the administration of the prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.
  • Perform activities for MQA (i.e., Packaging line clearances, manufacturing room clearances, inspection of third-party contractor lots. Maintains documentation in accordance with internal procedures and regulatory requirements (i.e., GMP, SOPs, etc.)
  • Works closely with Logistics / Supply Management on scheduling/distribution needs to appropriately manage workload.
  • Preparation of Investigation and Change Control elements for Annual Product Review Reports (APRs).
  • Collaborates with other facility colleagues to assure alignment of cGMP documentation practices where appropriate.
  • Supports and maintains an environment that fosters communication and teamwork within QA and related departments.
  • Responsible for compliance with Controlled substance documentation and accountability procedures while maintaining high alert to diversion and theft possibilities.

Education and Experience:

  • Requires a Bachelor’s degree, preferably in a scientific discipline,
  • 6+ years of experience in a pharmaceutical ( (i.e. tele, med/surg, vents, etc.) or related industry or graduate degree (MS preferred) with two years of experience in a pharmaceutical or related industry .
  • Specialties Needed: Veeva experience is a plus.

Necessary Knowledge, Skills, and Abilities:

  • Investigation into any unexplained discrepancies must be evaluated in terms of cGMPs, FDA requirements, NDA commitments and impact on product quality, safety and efficacy.
  • Incumbent must be able to drive deviations to determine true root cause and identify appropriate CAPAs to prevent recurrence.

1.Help Quality team to meet day-to-day assignments

2.Demonstrate excellent understanding of cGMP’s, FDA regulations, and pharmaceutical manufacturing processes.

3.Identifies and resolves in-depth issues through collaboration with others.

4.Partners with colleagues in identifying and resolving potential compliance concerns.

5.Interfaces with appropriate Warehousing, Planning, Pharmacy, Operations and Quality management to implement the procedural requirements as outlined and within internal operating procedures.

6.Identifies and proposes opportunities for continuous improvement to quality systems

7.Effectively performs root cause analyses and determines corresponding corrective measures.

8.Working knowledge of Track Wise and Veeva is a plus Supervisory Responsibilities (if Applicable) N/A Additional Information cGMPs, FDA requirements and regulatory commitments govern the QA function of the Sr. Quality Specialist II

 

Company DescriptionAbout The Rockridge Group:

TRG is a privately held Limited Liability Company committed to connecting businesses with job seekers. We deliver high quality contingent personnel to our clients using our 3-step collaborative engagement model:
Collaborate. We partner with you to understand the unique needs of your business before we propose a solution.
Strategize. Based on your goals and staffing challenges, we develop high impact solutions designed for your industry.
Engage. We work with your team before, during, and after every engagement to deliver 100% satisfaction.
With over ten (10) years experience in the resource solutions sector, principals Greg Donner [link to bio] and Ronald Lom [link to bio] leverage the power of strategic partnership to create a powerful staffing model that improves your quality of hire.Company DescriptionAbout The Rockridge Group:\r
\r
TRG is a privately held Limited Liability Company committed to connecting businesses with job seekers. We deliver high quality contingent personnel to our clients using our 3-step collaborative engagement model:\r
Collaborate. We partner with you to understand the unique needs of your business before we propose a solution.\r
Strategize. Based on your goals and staffing challenges, we develop high impact solutions designed for your industry.\r
Engage. We work with your team before, during, and after every engagement to deliver 100% satisfaction.\r
With over ten (10) years experience in the resource solutions sector, principals Greg Donner [link to bio] and Ronald Lom [link to bio] leverage the power of strategic partnership to create a powerful staffing model that improves your quality of hire.