Quality Specialist

One of our large pharmaceutical clients is looking to hire a Sr Quality Specialist to join the EQ team. The individual will provide QA support for TAR-200 (including UPC) and TAR-210 projects, ensuring adherence to quality assurance processes and compliance with all company policies and procedures. 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.
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
-Sterilization-specific documentation
-New equipment qualification documentation

Own/support the following
-Own Child records for Change Controls in TrackWise
-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 Clinical Trial Material (CTM) 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 HR@insightglobal.com.To 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/.

Bachelor Graduate in Biology, option Biomedical Research
Minimum 5-10 years of experience working with pharmacuteical manuafcturng and/or medical devices
Minimum 3-5 years of experience working with external partners, preferably CMO partnerships
Expertise handing review and approval of batch record review, RFFP acitivites, CAPAs, Change Controls, deviations, quality product compliants, and risk assessments
Trackwise or Comet experience
Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
Excellent computer proficiency e.g MS Office, TrackWise, Minitab
Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
Ability to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

Experience with small molecule new product launches

Benefit packages for this role will start on the 31st 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.