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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 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.)

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and 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. Experience working with external partners, preferably CMO partnerships

Experience with Regulatory and Health Authority GMP responses and documentation requirements

Trackwise or Veeva and/or Comet Quality System experience