Job Description

RBW are excited to present an opportunity with a growing CDMO partner. They are extremely ambitious, presenting a portfolio of their own products with plans to launch 4 more by the end of 2024 but also offering a fantastic contract manufacturing service.

They work closely with partners to manufacture OTC products including liquids, ointments, and creams. With the diverse and expanding operations at this CDMO, they are looking to build out their team with a Manufacturing QA Associate.

This role is open to a variety of profiles including those from a Food and Beverage Manufacturing,

Medical Device Manufacturing, and Pharmaceutical Manufacturing background. If you come from a highly regulated industry and are looking for a move - please apply or contact me directly!

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.
• 3+ years of related experience in the pharmaceutical, food and beverage, 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.

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