QA Operations Associate

Job Title - QA Operations Associate
Location – Gaithersburg MD 20878
Duration- 6 Months

"GENERAL DESCRIPTION/FUNCTION:
Quality Associate (QA Operations) is responsible to provide Quality Assurance On-the-Floor support real-time for GMP Manufacturing of master/working cell banks, and biological bulk drug substance to be used for human consumption. Responsibilities include providing QA on the Floor oversight of manufacturing including observing critical processes executed GMP documentation review and supporting other QA functions as needed.
Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.

DUTIES & RESPONSIBLITIES:

Performs QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing.
Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices
Review and dispositions executed batch records and supporting documentation for completeness, accuracy and compliance
Reviews and approves Master Batch records and Master Standard Manufacturing Records.
Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
Participates in root cause analysis using methodologies, such as: fishbone, 5 whys, comparative analysis, etc.
Act as QA reviewer for investigations, deviations and CAPA; with limited approval authority as designated by QA Management.
Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing.
Write, revise and approve GMP documentation as necessary
Works cross-functionally with Project Management, Manufacturing, Facilities, and Quality Control in meeting project deliverables in a compliant and efficient manner
Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary.
Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.

SKILLS & TECHNICAL EXPERTISE:

Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.
Creative individual with excellent analytical, trouble shooting, and decision-making skills
Ability to quickly learn new and Client manufacturing processes supporting new clients
Able to work in a team setting and independently under minimum supervision
Intermediate knowledge of Microsoft Office and database management sills, organization, record keeping skills required.
Familiarity with electronic systems, including developing and producing reports using Microsoft Access and Excel
Requires the ability to produce results in a fast-paced environment to meet client deadlines
Strong technical and quality background related to pharmaceuticals
Knowledgeable in pharmaceutical regulations relating to biologics is preferred
Able to effectively interpret new and existing global regulations
Able to communicate effectively with all levels of personnel and regulatory inspectors

Additional Job Details:

Minimum requirements: Minimum of a B.S. in a Life Sciences discipline

2 years’ experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks Exposure to Lean Operational Excellence highly desirable

Thanks & Regards,

Sai Sree Kuncha

Job Types: Full-time, Contract

Pay: $40.00 per hour

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• QA Operations: 4 years (Required)

Work Location: One location