Job Title: Deviation/Change Control/CAPA Lead

Job Description

The High-Level Quality Compliance professional will project manage pending Deviations, CAPA, and Change Control. This role ensures that all deviations, CAPAs, and change controls are documented, analyzed, and resolved in compliance with regulatory requirements and company standards. The professional will lead thorough investigations into deviations within the pharmaceutical manufacturing process and QC laboratory operations, developing, documenting, and managing Corrective and Preventive Actions (CAPAs) to address quality issues. This role also involves overseeing and managing the change control process within the pharmaceutical manufacturing environment, ensuring all changes are evaluated, documented, and implemented in compliance with regulatory requirements and company standards.

Responsibilities

• Lead and manage investigations of deviations, non-conformances, and quality incidents in the manufacturing process.

• Conduct root cause analysis using various methodologies (e.g., Fishbone, 5 Whys, FMEA) to identify underlying issues and propose effective corrective and preventive actions.

• Document investigation findings, conclusions, and CAPAs in a clear and concise manner.

• Collaborate with cross-functional teams, including Production, Quality Control, Engineering, and Technical Service, to gather relevant information and ensure timely resolution of deviations, CAPA, and Change Controls.

• Ensure all investigations and changes are conducted in compliance with GMP, FDA, EMA, and other regulatory requirements.

• Develop and implement CAPAs to prevent recurrence of deviations and improve overall process quality.

• Develop and document comprehensive CAPAs based on investigation findings, root cause analysis, and regulatory requirements.

• Develop CAPA effectiveness checks based on scientific rational and appropriate statistical measures.

• Prepare and present investigation reports to upper management.

• Stay current with industry trends, regulatory changes, and best practices related to deviation management, CAPA management, change control management, and quality assurance.

• Provide training and guidance to junior staff on deviation investigation techniques, CAPA writing techniques, change management process, and regulatory requirements.

• Oversee and manage the change control process, including the evaluation, documentation, approval, and implementation of changes.

• Conduct risk assessments and impact analyses to identify potential risks and develop mitigation strategies.

• Monitor the implementation of changes to ensure they are executed as planned and do not negatively impact product quality or compliance.

Essential Skills

• Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy) or equivalent experience.

• Minimum of 7-10 years of experience in pharmaceutical manufacturing, with at least 5 years in a quality compliance or quality assurance role.

• Strong knowledge of GMP, FDA, EMA, and other relevant regulatory requirements.

• Proven experience in conducting root cause analysis and implementing CAPAs.

• Proven experience in managing change control processes and conducting risk assessments.

• Excellent analytical, problem-solving, and decision-making skills.

• Strong written and verbal communication skills.

• Ability to work effectively in a team environment and collaborate with cross-functional teams.

• Detail-oriented with a strong focus on quality and compliance.

• Proficiency in using quality management systems (QMS), investigation tools, and change management tools.

Additional Skills & Qualifications

• Experience in batch record review and SOP management.

Work Environment

The work hours are 8am-5pm, onsite five days a week. You will serve as the Subject Matter Expert (SME) for all work towards deviation, collaborating with multiple teams and providing training.

Pay and Benefits

The pay range for this position is $65.00 - $72.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Sellersville,PA.

Application Deadline

This position is anticipated to close on Mar 31, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.