Quality Operations, Analyst II, Floor Support
About The Position
The Quality Operations, Analyst II, Floor Support supports quality activities in a biotechnology manufacturing environment by providing quality oversight of good manufacturing practice operations to help ensure compliance, product quality, and patient safety. This individual-contributor role reports to the QA Operations Manager and works closely with Manufacturing, Facilities, Engineering, Quality Control, Regulatory Affairs, and Quality Systems teams to help maintain inspection readiness and support the release of high-quality products. The role handles problems of limited scope and complexity, follows established policies and procedures, and makes decisions within a defined scope using standardized methods. It applies developing knowledge of basic principles, theories, concepts, industry practices, and standards. The position typically requires relevant experience, with contributions primarily related to task-specific activities. It works under moderate direction and close supervision, following specific, detailed instructions. The position is based at Takeda's USA - MA - Alewife - BIO OPS location. The listed shift is 2 p.m. to 12:30 a.m. Work may involve multiple shifts, weekends, and supplemental hours as necessary. The work environment includes indoor manufacturing and controlled environments requiring special gowning and protective clothing, potentially including hearing protection. Conditions may be cold or wet and may include clean rooms or cool/hot storage, moving equipment and machinery, and chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection. Makeup, jewelry, contact lenses, nail polish, and artificial fingernails must be removed in the manufacturing environment.
Requirements
- At least 3 years of experience in Quality Assurance, manufacturing, Quality Control, validation, or a related good manufacturing practice-regulated field.
- Knowledge of good manufacturing practice, good documentation practices, data integrity, quality systems, and quality risk management.
- Ability to review documentation and resolve quality issues.
- Solid interpersonal skills and great attention to detail.
- Team player with good problem-solving and good verbal and written communication skills.
- Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Proficient in Microsoft Word, Excel, Outlook, and SharePoint.
- Ability to work independently while contributing effectively in a multidisciplinary team environment.
- Ability to lift, push, pull, and carry up to 50 lbs without material handling equipment, and to push or pull pallets using material handling equipment.
- Ability to stand and/or walk for an extended period over an 8–12-hour shift between rooms and across the site.
- Ability to perform tasks that may require bending, twisting, reaching overhead, squatting, and repetitive motions involving hands, wrists, head, knees, and waist.
- Must not be colorblind and must have 20/20 near and distance vision, with or without glasses or contacts, for roles performing visual inspection only.
- Must follow manufacturing-area rules requiring removal of makeup, jewelry, contact lenses, nail polish, and artificial fingernails.
Nice To Haves
- Bachelor’s degree or higher with 4+ years of relevant industry experience in life sciences, engineering, chemistry, microbiology, biotechnology, or a related field is preferred.
- Experience with TrackWise, SAP, laboratory information management systems, electronic document management systems, or Veeva is preferred.
- Experience supporting regulatory inspections and internal audits is preferred.
- Training in Lean, Six Sigma, or American Society for Quality methods is preferred.
Responsibilities
- Provide routine quality oversight and real-time support of good manufacturing practice manufacturing operations.
- Perform manufacturing-area walkthroughs and compliance assessments to help ensure adherence to good manufacturing practice requirements, standard operating procedures, and regulatory expectations.
- Review, issue, and/or approve documents such as batch records, logbooks, protocols, reports, and supporting quality records.
- Support cross-functional teams in resolving quality and compliance concerns.
- Monitor quality metrics and trend data to identify compliance risks and support continuous improvement.
- Support deviations, corrective and preventive actions, change controls, internal audits, customer audits, and regulatory inspections as needed.
- Help maintain a state of continuous inspection readiness.
- Provide quality guidance and compliance coaching to manufacturing personnel and site partners.
- Improve documentation quality and Right First-Time performance.
- Contribute to a culture of quality, accountability, and continuous improvement.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
