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 (MBR) 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 MBR 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 commitment, and monitors progress during transitions
• Seeks continuous improvement and demonstrates accuracy and thoroughness
• Acts with integrity and respect; Upholds organizational values and inspires trust
• Develops strategies aligned with organizational strengths and goals
• Efficiently prioritizes, plans, and organizes tasks to meet objectives
• Treats others with respect, acts responsibly, and remains tactful under pressure
• Ensures accuracy, applies feedback, and consistently monitors work quality
• Meets productivity standards and strives to improve efficiency
• Follows safety guidelines, reports hazards, and uses materials properly
• Reliable, on time, and ensures responsibilities are covered when absent
• Follows instructions, takes responsibility, and completes tasks on time

Other Qualifications:

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The essential physical demands will vary for each Curia position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment:

The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must