Quality Assurance Operations Supervisor

Masis Professional Group

Bethlehem (Northampton County)

On-site

USD 90,000 - 105,000

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Paid paternity leave

Paid maternity leave

Tuition assistance

Disability insurance

Job summary

A leading pharmaceutical company in Bethlehem, PA is seeking a Quality Assurance Operations Supervisor to oversee GMP quality activities in a regulated environment. The role includes managing quality documentation and team supervision, with a focus on compliance and product quality. Candidates should have over 10 years of experience in the pharmaceutical or biotech industry, and a bachelor's degree is preferred. Competitive salary, bonuses, and excellent benefits are offered from day one.

Qualifications

10+ years of pharmaceutical or biotech industry experience.
Experience with QMS tools such as TrackWise, EDMS, or LMS.
Working knowledge of 21 CFR Parts 210, 211, and Part 11; Part 820 familiarity preferred.

Responsibilities

Oversee GMP quality activities supporting manufacturing operations.
Coordinate batch documentation review to support timely product release.
Supervise daily activities of the QA Operations team.
Collaborate with global QA partners for batch release activities.

Skills

GMP knowledge

Risk-based decision-making

Critical thinking

Customer service mindset

Excellent communication skills

Data analysis

Education

Bachelor's degree or equivalent experience

Tools

TrackWise

EDMS

LMS

Job description

Masis Professional Group provided pay range

This range is provided by Masis Professional Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$90,000.00/yr - $105,000.00/yr

Additional compensation types

Annual Bonus and Sign‑on bonus

Direct message the job poster from Masis Professional Group

Senior Recruiter | Pharmaceutical & Life Sciences Specialist

🧪 Quality Assurance Operations Supervisor | Bethlehem, PA

Join a well‑established, FDA‑regulated pharmaceutical manufacturing site in Bethlehem, PA that produces acute care drug products used in hospitals worldwide. This team is known for its strong quality culture, long‑term stability, and investment in people. Competitive salary, bonus eligibility and excellent benefits starting day one!

The Quality Assurance Operations Supervisor oversees GMP quality activities supporting manufacturing and packaging operations. This role plays a critical part in batch record review and disposition, deviations and CAPAs, OOS investigations, QC data review, and drug product complaint management to ensure regulatory compliance and product quality.

Coordinate batch documentation review with manufacturing and packaging teams to support timely product release.
Ensure API and drug product batches comply with GMP and regulatory requirements.
Supervise daily activities of the QA Operations team.
Mentor and coach team members while supporting succession planning.
Review production and QC documentation prior to batch disposition.
Ensure deviations, data integrity issues, and errors are investigated per internal procedures.
Oversee QC data review and OOS investigations.
Perform documented QA walkthroughs of manufacturing and packaging operations.
Collaborate with global QA partners to support batch release activities.
Manage the drug product complaint program, including investigations and reporting.
Prepare QA metrics for weekly, monthly, and quarterly management meetings.
Strong risk‑based decision‑making and critical thinking skills.
Ability to evaluate quality issues using GMP knowledge and data analysis.
High attention to detail with a proactive sense of urgency.
Strong customer service mindset and professional communication style.
Excellent written and verbal communication skills.
Motivated, energetic, and people‑focused leadership approach.
Bachelor’s degree preferred or equivalent experience.
10+ years of pharmaceutical or biotech industry experience.
Experience with QMS tools such as TrackWise, EDMS, LMS, or similar.
Working knowledge of 21 CFR Parts 210, 211, and Part 11; Part 820 familiarity preferred.