QA Lead Technical Operations

7 days ago

Devens, United States Actalent Full time

Great opportunity to get your foot in the door with one of the top Biopharmaceutical companies in the Devens, MA area

If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com.

Description

Work Schedule: Mon - Fri First shift 8:30AM - 5PM

Job Description/ Responsibilities:

  • Provides Quality Assurance QA support to Devens Site and reporting Manger through quality review and

approval of Investigations and Corrective Actions.

  • Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations

  • Reviews and approves Quality Quality Control Validation and Automation related documents

  • Review and approves Standard Operating Procedures SOPs.

  • Review and approval of Validation related documentation such as risk assessments protocols and test scripts and

summary reports.

  • Review and approval of change proposals as well as associated deliverables ensuring the change deliverables meet

external regulatory and internal WWQC guidelines and requirements.

  • Ability to coach across different departments within the subject matter of Investigations CAPAs general risk

assessments and Validation.

  • Ability to self-manage and prioritize work across multiple competing deliverables in a remote working

environment

  • Able to interpret complicated data and make sound decisions Independently

Sometimes will interact with departments listed below:

Quality Control

Manufacturing Operations

Manufacturing Engineering

Manufacturing Science and Technology MST

Validation

Site Engineering

Digital Plant

Education Experience and Qualifications:

  • Knowledge of science generally attained through studies resulting in a B.S in Biological science Engineering

biochemistry or related discipline or its equivalent is preferred.

  • Advanced Level of relevant experience in a GMP GCP or GXP with at least 8 years focused on product

quality. Preferred Active member of ASQ or ISPE.

  • Prior experience of QC equipment Qualification and some project management experience

  • Knowledge of biotech bulk drug substance or finished product manufacturing medical device analytical testing is

highly desirable.

  • Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.

  • Knowledge of electronic systems including any of the following: SAP LIMS TrackWise Veeva Vault and electronic

or paper based batch records desirable.

  • Excellent Technical writing and oral communication skills are required as well as experience in problem solving

  • Knowledge of Data integrity principles

  • Proven attention to details

  • Comfortable working in an FDA regulated environment.

Pay and Benefits

The pay range for this position is $50.00 - $65.00

• 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 onsite position in Devens,MA.

Application Deadline

This position will be accepting applications until Dec 6, 2024.

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent

  • Maintaining an inclusive environment through persistent self-reflection

  • Building a culture of care, engagement, and recognition with clear outcomes

  • Ensuring growth opportunities for our people

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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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