Associate Quality Assurance NS

Job Description

Job Description

Job Title: Associate Quality Assurance Specialist

Job Description

This role focuses on providing hands-on quality assurance guidance and support within a pharmaceutical production environment. You will review and approve quality batch records for all commercial batches labeled and packed at the site, while also contributing to various QA projects and systems. The position requires close collaboration with cross-functional stakeholders to ensure that all operations comply with Good Manufacturing Practices (GMP) and internal quality standards.

Responsibilities

• Provide daily quality assurance guidance and support to production staff to ensure strict adherence to Standard Operating Procedures (SOPs) and Work Instructions.
• Maintain a regular presence on the device assembly and packaging lines to monitor GMP operations, quality systems, and compliance in real time.
• Act as the first point of contact for quality-related production queries during packaging and labeling operations, providing timely and accurate guidance.
• Review and approve batch production records and other GMP documentation to support daily production activities, including performing required data entries prior to production.
• Perform finished product checks during commercial production runs to verify conformance with quality specifications and regulatory requirements.
• Compile and review batch records for lots assembled, packaged, and labeled at the site in preparation for batch disposition.
• Own, review, and approve controlled documents such as Standard Operating Procedures (SOPs), Work Instructions, and Forms to ensure they remain accurate and up to date.
• Review and approve Deviation, Corrective and Preventive Action (CAPA), and Change Control records to support continuous improvement and regulatory compliance.
• Support and participate in QA-related projects and systems as assigned, contributing to process improvements and enhanced quality controls.
• Establish and maintain effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance, and engineering teams.
• Adhere to all safety rules and maintain a safe work environment for yourself and others by following established safety procedures and reporting potential hazards.

Essential Skills

• Knowledge of Good Manufacturing Practices (GMP) within a regulated manufacturing or pharmaceutical environment.
• Experience or strong interest in quality assurance and quality control activities in a production setting.
• Ability to review, interpret, and approve batch production records and GMP documentation with a high level of accuracy and attention to detail.
• Capability to provide clear, concise guidance to production staff on SOPs and Work Instructions.
• Strong documentation skills, including experience working with controlled documents such as SOPs, Work Instructions, Forms, and quality records.
• Ability to evaluate and support Deviation, CAPA, and Change Control processes.
• Effective communication skills for interacting with production, warehouse, facilities, maintenance, and engineering stakeholders.
• Commitment to safety and adherence to established safety rules and practices.
• Entry-level candidates with a Bachelor’s degree in a Science discipline, or
• An Associate’s degree with at least 6 months of GMP, FDA, or similarly regulated experience, or
• Non-degreed candidates with 1–2+ years of heavily regulated manufacturing experience (such as food or pharmaceutical manufacturing, compounding, or similar).

Additional Skills & Qualifications

• Prior GMP experience beyond the minimum requirements.
• Experience with SAP and Manufacturing Execution Systems (MES).
• Scientific experience in a scientific or laboratory environment.
• Demonstrated ability to work effectively in a highly regulated, fast-paced manufacturing setting.
• Interest in long-term career growth within pharmaceutical or biotech manufacturing.

Work Environment

This position is based in a highly regulated pharmaceutical and biotech manufacturing facility that produces general medicine, rare disease, inflammation, and oncology products. You will work primarily in device assembly and packaging areas, closely aligned with production operations and quality systems. The role follows 12-hour shifts, typically from 6:00 PM to 6:30 AM, with schedules generally ranging from 3 to 4 days per week; shift patterns may fluctuate over the duration of the assignment. The environment emphasizes strict adherence to GMP, documentation control, and safety procedures, and offers exposure to large-scale expansion projects that create opportunities for professional development and growth

This is a Contract position based out of New Albany, OH.

The pay range for this position is $21.00 - $23.00/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)

This is a fully onsite position in New Albany,OH.

This position is anticipated to close on Jun 18, 2026.

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.

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 View email address on ziprecruiter.com 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.