Product Quality Assurance Associate

Beacon Hill; Chapel Hill (NC); On-site; Full time

Job summary

A leading company in the biotechnology sector is seeking a Contract Associate for Product Quality Assurance. This role involves ensuring compliance with Good Manufacturing Practices at a facility in RTP, NC. The ideal candidate will have a scientific background and experience in the pharmaceutical industry, with responsibilities including batch record review and supporting quality metrics. The position requires on-site work with a flexible schedule during peak times.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• Experience in pharmaceutical/biotech industry preferred.
• Ability to work in a cleanroom environment.
• Excellent verbal and written communication skills.

Responsibilities

• Ensure GMP compliance in QC, manufacturing, and facilities operations.
• Assist with product disposition activities.
• Communicate significant issues to senior management.

Skills

Communication

Attention to detail

Team player

Education

Bachelors or Advanced degree in a scientific discipline

Job description

Direct message the job poster from Beacon Hill

Senior Staffing Consultant II - Pinnacle Performer at Beacon Hill - Life Sciences Division

Job Title: Contract Associate, Product Quality Assurance

Location: RTP, NC

Remote Flexibility: MUST BE ABLE TO WORK ON-SITE DAILY FROM 12PM TO 8PM and willing to have flexible schedule during peak times

Contract Term: 6 months - covering leave

Position Overview: The Associate, Product Quality Assurance will be responsible for supporting Quality's oversight of laboratory and manufacturing operations at a manufacturing facility in RTP, North Carolina. The role will support plant start-up and routine operations to ensure systems and processes are maintained to ensure compliance to Good Manufacturing Practices, and ultimately to Good Distribution Practices as the programs move to the commercial phase. This role will provide Manufacturing Shop Floor Quality presence. The responsibilities of this role will cover aspects of the Product Quality Assurance team including, batch record review, logbook review, work order approvals, and support of product disposition activities. The position will report to the NC, Product Quality Assurance Director. The Associate, Product Quality Assurance is expected to be an on-site resource, with an alternate shift schedule, for project start-up and routine clinical and commercial operations.

Primary Responsibilities:

• Responsible to ensure GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations.
• Responsible for assisting with product disposition activities of supply produced at the manufacturing facility.
• Real time issuance and review of batch records and labels.
• Communicating lot disposition pending issues to management.
• Responsible for supporting functional and facility goals and objectives.
• Responsible for supporting and contributing to quality metrics for the facility.
• Responsible for communicating escalation of significant issues that may impact patient safety, product quality, supply, regulatory compliance, or the company brand image to senior management.
• Embodies the cultural values and aligns daily actions with departmental goals and company culture.

Qualifications:

• Bachelors or Advanced degree in a scientific discipline.
• Preferred experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
• Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually as well as within a multi-disciplinary team.
• Excellent listening, communication and interpersonal skills fostering team spirit.
• Consistent delivery of high-quality work at all times.
• Ability to gown and work in a cleanroom environment.
• Must be able to work onsite daily from 12 to 8pm and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance, Manufacturing, and Science

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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