Manufacturing Operations Manager

4 days ago

Austin, Texas, United States PSC Biotech Full time
About PSC Biotech
PSC Biotech is a global leader in life sciences services, dedicated to ensuring the highest standards of product development, manufacturing, and distribution. With strategically located offices worldwide, we offer a unique opportunity for skilled professionals to drive success in our team.

Our Mission
We aim to provide exceptional quality and regulatory compliance, while fostering a culture of innovation and collaboration. Our team is passionate about delivering results that exceed client expectations, and we're committed to empowering our employees to grow and succeed.

Job Summary
We're seeking an experienced Manufacturing Supervisor to oversee production operations, ensuring quality, regulatory, and cGMP compliance. This W2 Temp 6-month position offers a competitive salary, with potential for extension based on performance.

About the Role
In this key leadership position, you'll be responsible for driving manufacturing efficiency, optimizing production schedules, and implementing cost reduction initiatives. You'll work closely with the team to ensure compliance with quality and regulatory requirements, as well as contribute to the development of training programs and team member growth.

Responsibilities
- Oversee required production areas and effectively set and meet department goals, ensuring product compliance and quality standards.
- Manage production schedules to maximize efficiency and service. Address labor and material shortages proactively and implement optimized solutions.
- Conduct thorough investigations and root cause analyses to identify potential risks to processes, and implement proactive solutions. Lead CAPA implementation as required.
- Write, review, and approve required documentation including but not limited to operating procedures, batch records, exception documentation, risk assessments, etc.
- Contribute to cost reduction initiatives, analyzing and developing material, resourcing, and capital expenditure budgets.
- Train and mentor team members, ensuring completion of safety and compliance training, and contributing to the development of required training areas.
- Determine adequate resourcing and assist in hiring and developing team members as needed.

Requirements
- Associate's degree or higher in a related field.
- 3-5+ years of experience in cGMP manufacturing, preferably in a lead or supervisor role.
- Experienced in clean room environments.
- Strong understanding of quality and regulatory requirements (cGMP, FDA, etc.).
- Proven experience leading root cause analyses, risk assessments, and CAPA implementation.
- Excellent technical writing skills and strong understanding of technical documentation requirements.
- Excellent communication and interpersonal skills.
- Strong organization and time management skills.
- Quality driven with excellent attention to detail.
- Ability to follow full gowning procedures and requirements.
- Proven success in leadership, ability to coach and mentor employees.

Benefits
This W2 Temp position includes medical and sick time benefits, providing a comprehensive compensation package for the successful candidate. Additionally, PSC Biotech is committed to Equal Employment Opportunity and welcomes applications from diverse candidates.

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