QS Associate - Document Release (2nd Shift)

Page Mechanical Group, Inc.; Mainland (PA); On-site; USD 40,000 - 70,000; Full time

Job summary

Join a dynamic team as a QS Associate in a full-time role where you will ensure adherence to cGMP standards and play a critical role in quality assurance processes. This position involves managing the Annual Drug Product Review, supporting change control, and performing essential inspections and testing. You will be part of an innovative company that values its employees and offers a competitive salary package along with comprehensive benefits. If you are detail-oriented and passionate about quality assurance in a manufacturing environment, this opportunity is perfect for you.

Benefits

Competitive Salary Package

401(k) Retirement Plan

Vested Company Match Contribution

Paid Time Off

Health Savings Account

Life Insurance with Optional Supplemental Plan

Short-Term Paid Disability

Health Advocacy Programs

Qualifications

• College degree required; 0-2 years of Quality Control experience.
• LIMS experience is necessary for the role.

Responsibilities

• Ensure compliance with cGMP standards and manage the ADPR process.
• Initiate investigations and manage the CAPA process effectively.
• Perform production line inspections and maintain documentation.

Skills

Good Documentation Practices

MS Office applications

Interpersonal skills

Attention to detail

Basic math skills

Effective communication skills

Ability to read, write and understand English

LIMS experience

Education

College degree

Tools

Balances

Torque meters

Vacuum/seal strength testers

Job description

QS Associate - Document Release, Full-Time (2nd Shift)

Accupac is hiring for a full-time QS Associate to join our 2nd shift team at our Mainland, PA. facility.

Basic Job Functions:

Ensure company-wide adherence to cGMP standards, Standard Operating Procedures, and customer specifications.

Benefits

We believe our most valued resource is the people we work with. Most of our positions offer the following employee benefits:

• Competitive Salary Package
• 401(k) Retirement Plan
• Vested Company Match Contribution
• Paid Time Off
• Health Savings Account
• Life Insurance with Optional Supplemental Plan
• Short-Term Paid Disability
• Health Advocacy Programs

Essential Functions of the Job:

• Manage the Annual Drug Product Review (ADPR) process.
• Support the Change Control process including initiation, approvals, and closure.
• Initiate and participate in investigations (including Laboratory Investigations).
• Manage the CAPA process including initiation, closure and performance of Effectiveness Checks.
• Ensure compliance to cGMP standards in the Manufacturing and Packaging areas.
• Perform Production line inspections.
• Issue and perform review of logbooks and notebooks. Perform daily calibration checks of packaging equipment.
• Perform daily checks of temperature monitoring units and notification to management/facilities of excursions.
• Reconcile staged components with approved bill of materials.
• Sample, inspect, and approve customer and vendor components.
• Sample, identify, and submit customer and vendor raw materials to the lab for testing.
• Perform all required testing at established frequency.
• Record all test and inspection results immediately and accurately.
• Compile, organize, and review documentation from customers, Manufacturing, Packaging, and Laboratories.
• Draft, review and approve component MARS, manufacturing batch records, and packaging batch records.
• Review and approve batch records for release of customer product.
• Resolve any documentation discrepancies related to assigned tasks.
• Update paper and electronic records.
• File and archive documentation.
• Perform other duties as assigned.

Minimum Requirements of the Job:

• Comply with all company policies, SOP’s, current Good Manufacturing Practices and other relevant regulatory requirements.
• Maintain training at or above 90% of assigned curriculum.
• Possess Good Documentation Practices.
• Possess a working knowledge of MS Office applications (word, excel, etc...)
• Attention to detail.
• Ability to work individually and in groups.
• Interpersonal skills.
• Ability to perform basic math skills.
• Ability to read, write and understand English.
• Effective communication skills.
• Meet deadlines as assigned.
• Ability to read, inspect and match batch codes.
• Possess a working knowledge with the use of balances, torque meters, vacuum/seal strength testers, and computer.
• Demonstrate the ability to be flexible to changing requirements and duties of the position.

Physical Requirements:

• Ability to lift up to 40 lbs.
• Walking within the confines of the facility.
• Standing up to 80% of designated shift time.
• Good hearing (ability to hear alarms, ringing).
• Ability to bend/kneel to verify components.
• Ability to see colors and good sense of smell.
• Peripheral Vision.

Supervisory Responsibilities:

No

Education and/or Experience:

The QA Associate I must have a college degree and 0-2 years of Quality Control/Assurance experience in related field and LIMS experience. The QA Associate II must have a college degree, 2 plus years of Quality Control/Assurance experience in a related field and LIMS experience.

About Accupac

Accupac is a global contract development and manufacturing partner for beauty, personal care and healthcare brands. We develop and manufacture some of the world’s greatest products for global CPGs, emerging Indie brands, and everything in between. We make products that make a difference because we care about bettering the lives of people and the health of our planet.