Associate Data Review, Quality Control

BioSpace; Worcester (MA); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Paid time off (vacation, holidays, sick)

Medical/dental/vision insurance

401(k) plan

Short-term incentive programs

Long-term incentive programs

Job summary

A leading pharmaceutical company is seeking an Associate Data Review in Quality Control in Worcester, MA. The role focuses on quality assurance within operations and involves ensuring compliance with regulatory standards and participating in various quality initiatives. The ideal candidate will have a Bachelor's degree or relevant experience in the pharmaceutical field, along with strong communication skills. The position offers a comprehensive benefits package and opportunities for bonuses.

Qualifications

• Experience in Manufacturing, QA, QC, or R&D in pharmaceutical or biologics.
• Familiarity with Quality Systems and cGMP.
• Knowledge of Quality Systems, cGMP and regulatory requirements.
• Strong written and verbal communication skills.

Responsibilities

• Handle various aspects of quality assurance and quality control.
• Ensure products meet quality and regulatory standards.
• Support troubleshooting of quality compliance issues.
• Communicate Quality Management initiatives to management.
• Make quality decisions to ensure compliance with systems and cGMPs.

Skills

Quality assurance

Quality control

Communication skills

Education

Bachelor's Degree or 2+ years of experience in relevant fields

Tools

Electronic document management

Laboratory information management

Job description

Associate Data Review, Quality Control – BioSpace

Location: Worcester, MA (Marlborough, MA available)

Job Description

The Quality Associate supports the Quality Function that they are responsible for within Operations. This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance. Expectations that the Quality Associate will maintain high quality levels on all aspects of their job while achieving high levels of efficiency.

Responsibilities

• Responsible for various aspects of quality assurance and quality control related to their functional area.
• Ensures that product within the plant is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements.
• Support troubleshooting and resolution of quality compliance issues.
• Communicates with Management for Quality Management Review, Quality Initiatives, etc.
• Incumbent is responsible for quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs.

Qualifications

• Bachelor's Degree or 2+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry.
• Must be familiar with use of electronic document management and laboratory information management.
• Must also be familiar with Quality Systems as well as cGMP and other regulatory requirements.
• Strong communication skills, both oral and written.

Key Stakeholders

Development, Manufacturing, Quality and Regulatory

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html.

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html