Product Quality (PQ) Quality Assurance (QA) Specialist Job at Planet Group, Remote

NnpLSTZEbEZhTkp6TkdOTjRmZEV6S3BmOHc9PQ==
  • Planet Group
  • Remote

Job Description

Target PR Range: 38-48/hr
*Depending on experience

As a Product Quality (PQ) Quality Assurance (QA) Specialist, you will actively provide quality assurance support to the PQ organization as a subject matter expert of quality system records. In this team-based role you will directly add to the success of the Product Quality team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality and Process development on projects, issue resolution and investigations.
The QA Specialist will be encouraged to use technical abilities to lead and deliver quality assurance responsibilities while owning, reviewing, and/or approving Product Quality records and documentation including: product specifications, in-process control specifications, specification technical reports, annual product reviews (APRs), international expansion forms, change control records, appendix docs (data sheets and data analysis), Deviation Investigations/Root Cause Analysis, CAPAs, analytical comparability protocols, analytical comparability reports, and procedures.
As a team member you will be encouraged to use technical abilities to execute transactions in GMP systems (Veeva CDOCs, Trackwise, etc.) and may include additional business process support for APRs and audits, as needed. The QA specialist may also help with guiding products through the annual product review cycles.

Preferred Qualifications:
• Familiar with pharmaceutical sciences, quality, compliance and regulatory GMP requirements, associated with biologics and synthetic chemical manufacturing and QC testing.
• B.S. in biochemistry, chemistry, biology, or a related protein or synthetic biotechnology sciences field or an equivalent level of biopharmaceutical experience with responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
• Previous experience using VEEVA, Trackwise and other quality systems.
• Knowledge of biopharmaceutical bulk and drug product development, manufacturing, and/or Quality Control Testing
• Strong project management skills.
• General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals.
• Previous experience working on a cross-functional team in a matrix environment.
• Excellent written and verbal communication skills, including facilitation and presentation skills.

*CO/NYC candidates might not be considered

Job Tags

Remote job, Contract work,

Similar Jobs

Travel United Group

Blog Writer - Travel 365 Media Job at Travel United Group

 ...ideas, headlines, and visuals for social sharing Requirements Qualifications: ~2+ years of content writing, journalism, or blogging experience (travel preferred) ~ Exceptional writing, grammar, and storytelling skills ~ Familiarity with SEO... 

National Mortgage Staffing

On-Site Mortgage Jr Operations Manager Job at National Mortgage Staffing

 ...Our client is a small broker that is seeking a Mortgage Operations Manager. National Mortgage Staffing is currently seeking a Jr Operations...  ...of Mortgage- from A-Z ( Processing- Closing, Underwriting, compliance). This is a small company, you will be working in all... 

American Conservation Experience

Conservation Crew Member Job at American Conservation Experience

 ...our public lands and environment? Join American Conservation Experience (ACE) and receive free housing, hands-on skills training, AmeriCorps education award eligibility, and the chance to work in popular National Parks, Forests and local natural protected areas. This is... 

Peachford Hospital

RECREATION THERAPIST-PRN Job at Peachford Hospital

 ...Therapist Peachford Hospital is searching for an experienced Recreational Therapist to work on our Expressive Therapy Team. What Role Will You Play? Expressive Therapists serve as members of interdisciplinary treatment teams and provide therapeutic expressive... 

ProPivotal Staffing

Senior Accountant (CPA needed) Job at ProPivotal Staffing

 ...Senior Accountant (CPA needed) We are looking for a Senior Accountant to oversee the research, analysis, and documentation of complex accounting matters, including revenue recognition, purchase accounting, lease accounting, and impairment assessments. This role is responsible...