Senior QA Support- Phoenix, AZ (REMOTE) - REF10355S

Company: ProPharma Group
Location: Portland
Posted on: May 12, 2022

Job Description:

Company Description

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.

Job Description

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 project.
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.

Qualifications
Qualified candidates will possess a Bachelor's degree in scientific or engineering discipline along with 5 plus years related industry experience.
Proficient in Microsoft Word, Excel, Power Point and Project.
General knowledge of quality system elements and cGMP regulations.
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 information/instructions accurately.
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 the US.

Additional Information

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 succeed.

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