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Description

The Senior Product Quality Assurance (PQA) Analyst has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending, and perform annual Product Quality Reviews. This person also acts as a liaison between regulatory areas and TPM plants for regulatory submission.

Responsibilities:

•Maintains an effective liaison and cooperative relationship with other Areas including but not limited Quality, Regulatory, Technical, Supply Chain, along with the TPM sites.

•Ensures that bulk drug substance and/or drug product production at TPM sites is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions provided by QA Operations.

•Ensures TPM procedures including but not limited to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site.

•Review and approve manufacturing directions to the production floor.

•Provide support to PQA in global projects and events to ensure intended results are achieved; including planning, risk analysis, and implementation.

•Ensures investigations of TPM plant events related but not limited to process, laboratory, raw materials are completed thoroughly and documented accurately, including adequate product impact analyses and corrective and preventive action for plant events are documented.

•Perform annual Product Quality Review according to the company to comply with regulatory requirements.

•Participates in Trend Review Board to monitor process track and trending.

•Participates in the Global Change Review Board (GCRB) meeting as TPM representative to evaluate global changes related but not limited to supplier change notifications, process, laboratory, and regulatory submissions that impacts all sites.

•Generates detailed change management plans related to TPM plants changes to ensure intended results are achieved; including planning, risk analysis, and implementation.

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Qualifications:

•Bachelor’s degree preferably in Engineering or Science

•Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process

•Knowledge of GMP regulations and standards affecting pharmaceutical products

•Comprehensive knowledge and application of business and quality concepts

•Strong analytical skills and attention to detail

•Change plan, Exception Reports, SAP and LRMS experience is highly preferred

•Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences

•Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization

Pay and Benefits

The pay range for this position is $45.00 - $52.00/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 hybrid position in Waltham,MA.

Application Deadline

This position is anticipated to close on Oct 17, 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.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.