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Job Title: QA AnalystJob Description

Contribute to the success of customers by ensuring quality through the auditing of the facility and production lines, evaluation of raw material, bulk, and finished products, and continuous improvement efforts.

Responsibilities

+ Perform reviews of Production Batch Records to maintain a world-class manufacturing control program with training and a focus on first-time right.

+ Ensure documentation records are accurate and comply with GDP requirements.

+ Ensure compliance with current SOPs, Work Instructions, and test procedures.

+ Train personnel to improve compliance with regulatory and quality requirements.

+ Provide technical, process direction, and training to manufacturing personnel.

+ Utilize interpersonal skills to foster a culture of quality and increase quality awareness.

+ Document and investigate deviations and out of specification (OOS) situations.

+ Ensure SOPs, Work Instructions, controlled forms, and test methods are updated proactively to support improvements and compliance.

+ Ensure product quality specifications and customer standards are met and maintained.

+ Complete approvals to run as needed.

+ Ensure quality events are properly documented and escalated for efficient decision-making.

+ Ensure products meet specification prior to release.

+ Maintain current reference and product standards.

+ Ensure specifications are updated as needed.

+ Utilize data to focus improvement efforts to meet customer and regulatory requirements.

+ Accurately record data and pertinent information.

+ Use data to resolve ongoing quality issues on the floor permanently.

+ Document OOS situations, determine root cause, and suggest possible solutions to prevent recurrence.

+ Maintain compliance with current regulatory expectations and practices.

+ Understand and maintain a culture of 'lean action' within the department.

+ Implement and maintain standards and processes to eliminate waste throughout the department.

+ Apply and utilize lean tools to permanently implement improvements.

+ Institutionalize 5-S in all aspects of the department.

Essential Skills

+ Bachelor's degree in Chemistry, Biology, or related field.

+ 1-2+ years of GMP experience in pharmaceutical, medical device, or cosmetics industries.

+ Experience reviewing batch records and/or compounding records.

Additional Skills & Qualifications

+ Working knowledge of cGMP & 21CFR regulations.

+ Experience with investigations & deviations.

+ Attention to detail.

+ Ability to multi-task.

Work Environment

The position is based at the Eden Prairie site. The majority of time will be spent on the manufacturing floor to ensure equipment is running efficiently and the area is properly cleaned. When not on the floor, time will be spent in a desk environment reviewing batch records, writing protocols, and assisting with investigations. Work hours are Monday - Thursday, 4 am - 2 pm, with optional voluntary overtime on Fridays.

Pay and Benefits

The pay range for this position is $25.00 - $29.00/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 fully onsite position in Hopkins,MN.

Application Deadline

This position is anticipated to close on Jun 6, 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.