Process Control Specialist

Process Control Specialist

Build your future at Curia, where our work has the power to save lives.

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

We proudly offer:

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

The Process Control Specialist is responsible for the timely review of manufacturing batch records (M ) and the tracking of batch record key process indicators. Additionally, this role will collaborate with other departments, such as Quality Assurance, as part of the M  review process.

Essential Duties and Responsibilities:

• Assists with investigations, document revisions, protocol development, and CAPA projects, helping ensure timely and accurate completion
• Presents findings to leadership, makes recommendations, and resolves issues as necessary
• Acts as a key point of contact for addressing operational challenges to ensure smooth workflow continuity
• Responsible for compiling, analyzing, and presenting shift information to relevant support teams and the oncoming shift management team, ensuring accuracy and timeliness in reporting
• Takes corrective actions as needed to maintain operational efficiency and compliance with organizational goals
• Responsible for assisting the Production Shift Manager and Production Shift Supervisor in the daily operations of the business unit on shift
• Responsible for reviewing all Master Batch Records for completeness, content and clarity
• Responsible for ensuring compliance with CGMPs, corporate and site-specific policies, and procedures
• Assist with maintaining and reporting metrics to evaluate the performance of the business unit
• Assist with the bench strengthening and in-depth cross-functional training of all members of the business unit
• Responsible for the adequate supply and replenishment (placing orders) of various supplies and operational equipment
• Assist the Technical Operations group with projects and process improvements
• Archival of documents needed to support Production activities
• Must become fluent in all functional areas in the business unit
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties as assigned

Education:

• High school diploma or GED

Experience:

• Minimum of four (4) years related work experience OR
• Minimum of three (3) years in pharmaceutical or related industry

Language

Skills:

The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.

Mathematical

Skills:

Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer

Skills:

The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

Other

Skills and Abilities:

• Fosters a collaborative and positive work environment
• Champions change
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• Demonstrates strong organizational skills and attention to detail
• Identifies and resolves problems in a timely manner
• Strives to continuously build knowledge and skills and shares expertise with others
• Speaks clearly and persuasively;
  Listens, clarifies, and responds well to questions;
  Participates effectively in meetings
• Writes clearly and edits for accuracy;
  Adapts writing style as needed and presents data effectively
• Balances team and individual responsibilities;
  Welcomes feedback;
  Prioritizes team success and supports others in achieving goals
• Develops plans, communicates changes, builds…