Job Description

Logistics of the Role:

• 1 year contract minimum , most likely beyond that opportunity an FTE role could open up
• Location: Remote to start - travel up to 2x monthly to the onsite CMO in Grand Rapids, MI and Bloomington, IN
• 10 PTO Days, 6 sick days
• $45/hr-$50/hr- Exact compensation may vary based on several factors, including skills, experience, and education.
• Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Requirements:

• Bachelor degree in Scientific field
• Minimum 5+ years of experience working with GMP pharmaceutical manufacturing
• Hands on aseptic filling experience on the floor
• Up to date Annex 1 Requirement Knowledge
• Expertise handling review and approval of batch record review, RFFP activities, CAPAs, Change Controls, deviations, quality product complaints, product risk assessments, and annual product reports
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
• A motivated individual with the ability to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

Preferred:

• Experience working with external partners, preferably CMO partnerships
• Experience with Regulatory and Health Authority GMP responses and documentation requirements
• Trackwise or V eeva and/or Comet Quality System experience

Job Description: One of our large pharmaceutical clients is looking to hire a remote Quality Specialist to join the EQ team. The individual will provide QA support for External Manufacturers of biotherapeutic Drug Substance (API) and parenteral Finished Product. They will perform assigned duties and collaborate with cross-functional teams to maintain regulatory standards, facilitate communication within the core team, and help to ensure that all quality-related activities project goals and deadlines are met. This individual will be required to travel to EM sites up to 1x-2x per month.

In particular, the specific tasks required on a daily basis by the position are:

Support, review/pre-review, and/or approve the following -

-Batch record review

-Quarantine shipment (Q-ship) activities

-Release for Further Processing (RFFP) activities

-EM Quality Events

-EM CAPAs

-EM Change Controls

-EM Planned Deviations

-EM Product Quality Complaints

-EM Protocols

-EM Risk Assessments

-EM Electronic Batch Record (eBR) changes

-EM Manufacturing Process Instruction (MPI) changes

-EM equipment specific Master Validation Plan (MVP) changes

-New equipment qualification documentation

Own/support the following

- Own and execute change control activities

-Own/support internal Nonconformances (NC) in Comet

-Own/support internal Investigations in Comet

-Own/support internal Supplier Investigations in Comet

Help maintain/manage/keep organized the following

-Outstanding EM issues

-Transfer of document to the EM

-Status of lots/production schedule

-Various workstreams (help build templates, flowcharts, etc.)

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