In-Process Quality Assurance (IPQA) Specialist

Job Title: In-Process Quality Assurance (IPQA) Specialist

Job Description

We are seeking an experienced In-Process Quality Assurance (IPQA) Specialist to provide real-time quality oversight of sterile injectable manufacturing operations. This role is responsible for ensuring all production activities comply with current Good Manufacturing Practices (cGMP), approved procedures, regulatory requirements, and quality standards. The ideal candidate will have extensive experience within sterile pharmaceutical manufacturing and a strong background in shop-floor quality assurance, batch record review, deviation investigations, and aseptic processing oversight.

Responsibilities

• Perform routine in-process quality inspections throughout manufacturing operations.

• Provide QA oversight during material dispensing, compounding, sterile filtration, aseptic filling, and capping, lyophilization, visual inspection, and packaging operations.

• Conduct line clearance activities prior to manufacturing and packaging processes.

• Verify equipment cleanliness, calibration status, and readiness for use.

• Ensure compliance with approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), and cGMP regulations.

• Perform in-process sampling according to established procedures.

• Monitor critical process parameters and verify adherence to specifications.

• Review manufacturing documentation, logbooks, and production records for accuracy, completeness, and regulatory compliance.

• Verify material, equipment, and status labeling throughout production operations.

• Review executed Batch Manufacturing Records (BMRs) and Batch Production Records (BPRs).

• Assist with batch disposition and release activities.

• Conduct audit trail reviews for manufacturing equipment and systems.

• Identify, document, and escalate deviations, nonconformances, and quality events.

• Support investigations related to deviations, OOS results, and manufacturing events.

• Participate in root cause analysis and implementation of Corrective and Preventive Actions (CAPA).

• Ensure adherence to Good Documentation Practices (GDP) and Data Integrity principles (ALCOA+).

• Verify environmental monitoring activities are performed according to schedule.

• Ensure compliance with aseptic techniques and gowning procedures.

• Support media fills, validation activities, engineering batches, and equipment qualifications.

• Participate in internal audits, customer audits, and regulatory inspections.

• Promote a culture of quality, compliance, and continuous improvement throughout manufacturing operations.

Essential Skills

• 5+ years of Quality Assurance or In-Process Quality Assurance experience within a pharmaceutical manufacturing environment.

• Direct experience supporting sterile injectable manufacturing operations.

• Strong understanding of aseptic processing and sterile manufacturing regulations.

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, Biotechnology, or another Life Sciences discipline.

Additional Skills & Qualifications

• Current Good Manufacturing Practices (cGMP)

• FDA 21 CFR Parts 210 & 211

• EU GMP Annex 1

• Aseptic Manufacturing Practices

• Batch Record Review

• Line Clearance Procedures

• Environmental Monitoring Programs

• Data Integrity (ALCOA+)

• Deviation Investigation and CAPA Management

• Good Documentation Practices (GDP)

• Strong attention to detail and problem-solving abilities

• Excellent communication and cross-functional collaboration skills

Work Environment

The work environment is a GMP clean room, focused on maintaining high standards of sterility and regulatory compliance. Employees work in a highly regulated manufacturing environment committed to operational excellence and continuous improvement, ensuring the quality and compliance of life-saving sterile pharmaceutical products.

Job Type & Location

This is a Contract to Hire position based out of Boca Raton, FL.

Pay and Benefits

The pay range for this position is $36.06 - $46.67/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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)

Job Type & Location

This is a Contract to Hire position based out of Boca Raton, FL.

Application Deadline

This position is anticipated to close on Nov 24, 2026.

Workplace Type

This is a fully onsite position in Boca Raton,FL.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.