Production Specialist

Work Schedule

Environmental Conditions

About the Role

We are seeking a detail-oriented Production Specialist to support process excellence and continuous improvement initiatives within our GMP pharmaceutical manufacturing operations.

In this role, you will focus heavily on technical writing activities, including the creation, review, revision, and maintenance of Standard Operating Procedures (SOPs), manufacturing documentation, and process-related procedures.

You will partner with cross-functional teams to improve operational efficiency, strengthen quality systems, and ensure compliance with GMP standards.

Responsibilities

• Create, revise, review, and maintain SOPs, work instructions, and manufacturing documentation related to GMP pharmaceutical production processes and equipment.
• Partner with Manufacturing, Quality, Engineering, and Project Management teams to support process improvements and operational excellence initiatives.
• Conduct root cause investigations and support corrective and preventive action (CAPA) activities related to manufacturing processes and quality events.
• Evaluate current manufacturing procedures and workflows to identify opportunities for improved efficiency, compliance, and performance.
• Aid in the implementation of new or revised processes, including training production personnel across multiple shifts as needed.
• Participate in project teams and cross-functional meetings to ensure alignment on production and quality goals.
• Maintain accurate documentation practices while ensuring compliance with GMP, SOP, and safety requirements.
• Develop and maintain a strong understanding of pharmaceutical manufacturing processes, production equipment, and operational procedures.

Requirements

• Education: High school diploma or equivalent required. Additional technical training, certifications, or relevant coursework in manufacturing, pharmaceutical operations, or quality systems preferred.
• Experience: Minimum 4 years of experience in pharmaceutical manufacturing, GMP operations, quality systems, or related production environments. Experience with technical writing, including SOP creation, revision, and document control processes. Experience supporting continuous improvement or lean manufacturing initiatives preferred.
• Knowledge, Skills, Abilities: Strong understanding of Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and pharmaceutical manufacturing processes. Demonstrated technical writing and documentation management skills. Strong problem-solving and root cause analysis capabilities. Excellent organizational skills and attention to detail. Ability to work independently and collaboratively within cross-functional teams. Strong written and verbal communication skills. Proficiency with computer systems and Microsoft Office applications. Ability to wear required Personal Protective Equipment (PPE) and lift up to 50 lbs as needed.

Qualifications

• Physical Requirements: Moderate physical exertion is required, including lifting medium-weight objects, bending, crouching, stretching, and reaching. Frequent operation of equipment, including keyboards, and prolonged periods of walking, sitting, or standing are necessary. Regular exposure to manufacturing environments that may include dust, fumes, or odors is expected. Use of Personal Protective Equipment (PPE) and adherence to safety procedures is required.

Skills

• Continuous improvement mindset
• Accountability and ownership
• Effective communication
• Collaboration and teamwork
• Quality and compliance focus
• Adaptability and initiative

Benefits

We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond through innovative solutions for some of the world’s toughest challenges.

Pay

Competitive compensation package based on experience and qualifications.

Schedule

First Shift (Days)

Benefits

Health insurance, retirement plans, paid time off, and other benefits are offered to eligible employees.