QA Specialist: Batch Release

Actalent; United States; Remote; USD 48,000 - 69,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Savings Account

Transportation benefits

Employee Assistance Program

PTO / Vacation

Job summary

Actalent is seeking a QA Specialist to join our Quality & Compliance team in the biopharma sector. You will support QA processes, ensure regulatory compliance (FDA/ EMA), review batch records, investigate quality issues, and collaborate with CDMOs and internal CMC teams to safeguard product integrity throughout development and manufacture.

The role emphasizes maintaining a robust QMS, document control, audits, and preparation for regulatory filings.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum of 3 years biopharma operations, quality or QC/QA roles.
• Experience with audits, deviations, change control, CAPAs.
• Strong knowledge of GMP, GCP, ICH and US/EU/UK regulations.
• Strong interpersonal and leadership skills; able to build professional relationships.

Responsibilities

• Perform batch record review and release for US and ex-US trials.
• Investigate and address product quality issues, deviations and non-conformances.
• Collaborate with CDMOs and internal CMC teams to ensure quality from development to commercialization.
• Provide quality support to CMC throughout product lifecycle.
• Review and approve technical transfer docs: protocols, reports, master batch records, test methods.
• Maintain and improve the Quality Management System (QMS) per policies and regulatory standards.
• Assist in creating and maintaining SOPs, policies, and related documents.
• Compile metrics for internal and external operations and manage document control processes.
• Prepare for and support internal/external audits and address audit findings.
• Assist in regulatory filings and submissions.

Skills

GMP knowledge

GCP/ICH regulations

Quality Assurance

Documentation control

Auditing

Communication skills

Education

Bachelor's Degree in Life Sciences

Tools

QMS software

Job description

Job Title: QA Specialist Job Description

Join our dynamic Quality & Compliance team as a QA Specialist, where you will play a pivotal role in maintaining high-quality standards within the biotechnology industry. You will support quality assurance processes, ensure compliance with regulatory standards such as FDA and EMA, and collaborate with cross-functional teams to uphold product integrity and safety. This role demands a strong understanding of laboratory and manufacturing environments.

Responsibilities

• Perform batch record review and release in support of US and ex-US clinical trials.
• Investigate and address product quality issues, including deviations, OOS results, and non-conformances.
• Collaborate with CDMOs and internal CMC teams to ensure quality standards are met from development through commercialization.
• Provide Quality support to CMC throughout the product lifecycle.
• Review and approve technical transfer documents including protocols, reports, master batch records, and test methods.
• Implement, maintain, and improve the Quality Management System (QMS) in accordance with internal policies, procedures, regulatory requirements, and industry standards.
• Assist in the creation and maintenance of SOPs, policies, and associated documents.
• Compile metrics for internal and external operations.
• Support the management of document control processes, including reviewing and approving batch records, deviation reports, and change controls.
• Assist in preparing for internal and external audits and support in executing internal audits to ensure compliance with regulatory standards.
• Address and resolve audit findings, ensuring corrective actions are implemented.
• Assist in the preparation of regulatory filings and submissions.

Essential Skills

• Extensive knowledge of GMP, GCP ICH and US/EU/UK regulations.
• Experience supporting product technical transfer activities and comparability studies.
• Significant experience in drug manufacturing or biologics industry in Quality Assurance, Quality Control or Quality Engineering positions.
• Demonstrated knowledge of Quality Management Systems, preferably electronic systems.
• Bachelor's Degree in Life Sciences (Biology, Biochemistry, Biotechnology, etc.) or a related field.
• Minimum of 3 years experience in biopharmaceutical operations, technical operations, and/or quality operations, with 2+ years hands‑on experience in Quality function supporting clinical or commercial lifecycle management.
• Experience with audit processes, document control, and Quality Management Systems: deviations, change control management, and CAPAs.
• Strong interpersonal and leadership skills with the ability to build and maintain effective professional relationships.
• Effective presentation and writing skills.
• Ability to provide clear, pragmatic direction and advice regarding compliance issues.

Additional Skills & Qualifications

• Cell and gene therapy experience preferred.
• Experience in a startup early phase‑late phase setting highly desirable.

Work Environment

This is a flexible role with the option to work remotely, primarily during first shift hours. You will collaborate with a team of five within the QMS, including a manager and director. The position involves significant interaction with Technical Transfer activities.

This is a Contract to Hire position based out of Philadelphia, PA.

Pay and Benefits

The pay range for this position is $35.00 - $50.00/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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 26, 2026.

Equal Opportunity Employer

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.

Disability Accommodation

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 [e-mail] 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.