Manufacturing QA Associate

Location Indianapolis
Discipline: Quality Assurance
Job type: Permanent
Contact name: Cloe Broad

Contact email: Cloe.broad@rbwconsulting.com
Contact phone: +16178024167
Job ref: CBIN
Published: about 1 month ago
Expiry date: 09 Nov 2024 23:59
Startdate: ASAP

​Manufacturing QA Associate

  • CDMO - OTC, Non-Sterile Products

  • Portage, IN

  • 2 years experience in Quality in cGMP Manufacturing

RBW Consulting are excited to support a CDMO partner in the expansion of their Portage based team. With a keen focus on OTC products, they are producing a wide variety of products for Global partners.

With ambitious plans to launch new products in 2024, their priority is to have a talented and ambitious team. Starting with a Manufacturing QA Associate. You will join a team of 100 across 2 sites, on the floor working in close collaboration with the production team to ensure top quality and compliance.

Responsibilities

  • Provides GMP/GDP Guidance to ensure proper actions and documentation is taking place within the manufacturing space.

  • Performs AQL Testing on finished product by verifying various attributes such as product appearance, product and packaging dimensions, presence and accuracy of printing on strip and pouch, and seal integrity.

  • Performs line clearances for all steps of the manufacturing process.

  • Perform real time record review to ensure completeness and accuracy of the documentation and assist in obtaining any required corrections.

  • Reviews, assesses, and archives pest control documents.

  • Performs QA retain sampling; conducts analysis and documentation of results.

  • Spot checks and conducts facility walkthroughs for critical process steps to ensure adherence to policies, procedures and regulations.

  • Conducts problem solving/trouble shooting for incidents observed and initiates event reports for incident resolutions

  • Understands the manufacturing schedule and provides quality support to ensure business continuity. Ability to handle multiple assignments and projects with competing priorities while independently managing time is critical.

  • Operates with a sense of urgency in a fast-paced environment.

  • Ensures that the manufacturing environment is in a state of control through the evaluation of the building automated system software

  • Conducts routine audits and walkthroughs to ensure audit readiness at all times.

  • Verifies schedule and workflow adherence.

  • Communicates any non-conforming events (testing results, environmental conditions, documentation issues, etc.) to the Manufacturing Quality Associate and Operations Team Leads and management.

  • Performs other duties as instructed by quality management.

  • Leads and participates in special projects.

  • Acknowledges that this position requires off-hours and weekend work from time to time to assure adequate QA floor support while production is running.


Requirements

  • BS degree preferred in chemistry, biochemistry, or related science field highly desired.

  • 2+ years of related experience in the pharmaceutical, biotechnology, or medical device industry with increasing responsibility preferred.

  • Demonstrated knowledge of quality systems, GMPs, industry standards, and regulatory requirements for the manufacture, testing, and release of pharmaceutical products.

  • Technical proficiency at reviewing/auditing production records, reports and/or GMP related documentation.

  • Ability to work within a team environment and willingness to contribute to the overall goals of the company.

  • Strong technical writing skills.

  • Good problem-solving techniques and a demonstrated ability to troubleshoot.

  • Good organizational skills, high level of attention to detail, excellent oral and written communication skills with the ability to interact at all levels both internally and externally.

  • Experience working directly with regulatory agencies a plus.

  • Ability to lift up to 35lbs.

  • Must be willing to work off hour shifts and weekends as necessary.