Senior QA Support- Phoenix, AZ (REMOTE) - REF10355S
Company: ProPharma Group
Posted on: May 12, 2022
ProPharma Group is an industry leading, single source provider for
regulatory compliance, pharmacovigilance, and medical information
services across the full development lifecycle for pharmaceutical,
biotechnology, and medical device companies. Operating around the
world with offices in Australia, Canada, Germany, Japan, the
Netherlands, Sweden, United Kingdom, and the United States,
ProPharma Group's fully integrated service offerings will provide
clients with a comprehensive suite of global support services that
are required to be competitive in today's dynamic markets. We build
successful long-term relationships with clients by providing
leading industry knowledge, experience, and proven processes.
Client is looking for a Senior QA resource to review completed
Batch Records, Drafts, QC Test Records, Drafting Procedures,
Supplier Quality docs, etc. This is a fully remote, 3 month
General QA Administrative Support
Review draft QMS Procedures
Review of completed receiving and production documents (material
specifications, batch records, reagent QC)
Provide support to clients on quality issues such as OOS results,
deviations and non-conformances.
Provides Quality oversight of operations and data review for
accuracy, completeness, and conformance to current Good
Manufacturing Practices (cGMP) and company quality standards.
Provide training, executing audits, document creation,
communication, and oversight to meet the established quality goals
of the client and applicable regulations.
Provide assistance in performing internal and external GMP
compliance audits and annual quality review.
Qualified candidates will possess a Bachelor's degree in scientific
or engineering discipline along with 5 plus years related industry
Proficient in Microsoft Word, Excel, Power Point and Project.
General knowledge of quality system elements and cGMP
Experience providing support to clients with quality issues such as
OOS results, deviations and non-conformances arise. Also, provide
advisement for the implementation of proper CAPA to resolve
deviations and non-conformances.
Ability to write and revise Standard Operating Procedures.
Effective written and oral communication skills; ability to write,
type, express or exchange ideas; ability to convey
Carry out duties and responsibilities with limited supervision.
Flexibility to work occasional weekends and evenings.
Ability to walk, stand and move about for long periods of time;
work with equipment in the field including basic hand tools, lift
and manipulate reasonable weights (approximately 35 lbs.), ability
to sit and type for long periods of time.
Ability to plan and manage own work
Must be willing to travel regionally and/or nationally throughout
We celebrate our differences and strive to create a workplace where
each person can be their authentic self. We are committed to
diversity, equity, and inclusion. Employees are encouraged to
unleash their innovative, collaborative, and entrepreneurial
spirits. With a holistic approach as an Equal Opportunity Employer,
we provide a safe space where all employees feel empowered to
We are an equal opportunity employer. M/F/D/V
***ProPharma Group does not accept unsolicited resumes from
recruiters/third parties. Please, no phone calls or emails to
anyone regarding this posting.***
Keywords: ProPharma Group, Portland , Senior QA Support- Phoenix, AZ (REMOTE) - REF10355S, Other , Portland, Maine
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