- Monitors all operations pertaining to manufacturing to ensure adherence to AQST policies and procedures and provides guidance and clarity to colleagues to ensure consistent approaches to product quality are applied.
- Conducts routine internal audits and facility walkthroughs to ensure compliance with internal quality system requirements and to maintain a state of audit readiness.
- Initiates and investigates nonconformances, project managing to resolve quality issues by partnering with other functions.
- Author and review Forms, Batch Records, WI, SOPs, Protocols in electronic document management system
- Investigates assigned product quality complaints utilizing knowledge of the manufacturing and quality processes at Aquestive.
- Owns CAPA records and action item implementation, partnering with operations, supply chain, engineering, and QC staff to ensure corrective actions are implemented according to approved timelines and ensuring their effectiveness post-implementation.
- Coordinates the Environmental Monitoring program including scheduling of third-party water testing, sampling, and report generation.
- Short to medium term (3-12 months) project owner for quality projects to improve efficiency or compliance profile.
- Understands the manufacturing schedule and provides quality support to ensure business continuity and seamless transitions between manufacturing stages.
- Operates with a sense of urgency in a fast-paced environment.
- Performs real time review of operational records, including Batch Records, and assists in obtaining any required corrections.
- Pulls the AQL samples during packaging of finished product based on sampling instructions.
- Performs AQL testing by verifying appearance, weight, dimensions of pouch and strip, presence of print on strip and pouch, and seal integrity for each AQL sample pulled.
- Records results from each AQL test performed.
- Communicates AQL alert, action or failure limits to the Quality Assurance and Operation Supervisor.
- Segregates impacted population criteria based on AQL testing results and communicating criteria for such to the Operations Supervisor and packaging operators.
- Performs stability sampling, finished product sampling, micro and in process sampling and bringing samples to the lab, per the appropriate protocol or sampling instructions.
- Demonstrates good understanding of AQL procedures and guidelines after applicable training.
- Performs other duties as instructed by QA Supervisors.
- Trains and performs batch record review during production operations, line clearance and control procedures, IPC testing, scale/balance verification and other assigned production support duties as deemed appropriate.
- Minimum 2-year college degree in the Sciences (biology or chemistry) or equivalent experience.
- 2+ years in pharmaceutical or other regulated industry.
- Ability to understand and follow Standard Operating Procedures.
- Strong working knowledge of cGMPs.
- Demonstrated knowledge of quality systems, GMPs, industry standards, and regulatory requirements for the manufacture, testing, and release of pharmaceutical products.
- Formal training in Quality disciplines (auditing, engineering, process improvement) as demonstrated through certification (ASQ, Lean Six Sigma, etc.) highly preferred.
- 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.
- Ability to lead project teams.
- The ability to handle multiple assignments and projects with competing priorities while independently managing time is critical.
- Good organizational skills, high level of attention to detail, excellent oral and written communication skills with the ability to interact at all levels.
- Owns a driver's license and can travel between production facilities (<1 mile) as required.
- Must be willing to work off hour shifts and weekends as necessary.
- Basic math skills.
- Experience with Microsoft Office.
- Ability to lift up to 35lbs.
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
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MQA Quality Associate - Portage, United States - Actalent
Description
Description:
Responsibilities:
Skills & Qualifications:
Experience Level:
Entry Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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