Clinical-Scientific - Quality Assurance - Clinical

Position Details :

Our client, a world-leading Pharmaceutical Company in Andover, MA is currently looking for a Manufacturing Quality Specialist to join their expanding team.

Job Title : Manufacturing Quality Specialist (Batch records review) / Pharma Industry

Duration : 12 months contract, extendable up to 36 months

Location : Andover, MA

1st Shift, Monday - Friday, typically 8am -5pm (flex on times)

Note :

The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.

You may participate in the company group medical insurance plan

Job Description :

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.

Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pharmaceutical's dedicated and highly effective quality assurance team.

You will be responsible for providing Quality Assurance support to GMP clinical manufacturing. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures.

In addition, this position will perform a range of duties associated with records management to ensure compliance with regulatory requirements and company standards.

How You Will Achieve It

Review and approve various Good Manufacturing Practices also cGMP records (primarily batch records, formulation records).

Ensure that all documents for batch release are reviewed for completeness and accuracy.

Support the site relative to a constant state of inspection readiness.

Recognize when an issue is beyond your sphere of influence and escalate immediately.

May participate in the release of raw materials, as needed.

Basic Qualifications

Must-Have

Bachelor's Degree

Nice-to-have

Experience in pharmaceutical industry

Physical / Mental Requirements

Mental agility to handle a large quantity and broad scope of different types of quality assurance work.

Ability to work independently, problem solve and make recommendations for solutions.

Role is primarily office-sitting. Position requires walking, sitting, standing, and carrying batch records from one location to another as Andover site is a campus setting.

Non-Standard Work Schedule, Travel Or Environment Requirements

1st Shift, Monday - Friday, typically 8am -5pm (flex on times)

Work Location Assignment : Andover, MA. On Premise

Interviews : Teams Meeting

Teams Meeting

Minimum Education : Must-Have

Must-Have

Bachelor's Degree