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Qa Operations Specialist Jobs (NOW HIRING)

The Manager, QA Operations is responsible for the implementation of policies and procedures to ensure adherence to production quality standards and oversight of the Company's electronic ISO 13485 ...

Reporting to the Head of Global QA Operations/QP, the Director, QA Operations is responsible for leading Quality Assurance oversight of all Drug Substance (DS) and Drug Product (DP) manufacturing ...

$122K - $163K/yr

Reporting to the Head of Global QA Operations/QP, the Director, QA Operations is responsible for leading Quality Assurance oversight of all Drug Substance (DS) and Drug Product (DP) manufacturing ...

Director, QA Operations

San Francisco, CA · On-site

$122K - $163K/yr

Reporting to the Head of Global QA Operations/QP, the Director, QA Operations is responsible for leading Quality Assurance oversight of all Drug Substance (DS) and Drug Product (DP) manufacturing ...

Showing results 21-40

Qa Operations Specialist information

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$31.5K

$71.3K

$117K

How much do qa operations specialist jobs pay per year?

As of Sep 11, 2026, the average yearly pay for qa operations specialist in the United States is $71,279.00, according to ZipRecruiter salary data. Most workers in this role earn between $57,000.00 and $84,500.00 per year, depending on experience, location, and employer.

What is a QA Operations Specialist?

A QA Operations Specialist is responsible for ensuring that products or services meet established quality standards and regulatory requirements throughout the production or operational process. They develop, implement, and monitor quality assurance procedures, conduct audits, and collaborate with other departments to resolve quality issues. Their role is crucial in maintaining compliance, improving operational efficiency, and ensuring customer satisfaction by delivering high-quality outcomes.

How does a QA Operations Specialist typically interact with other departments to ensure product quality?

As a QA Operations Specialist, you will routinely collaborate with cross-functional teams such as production, supply chain, and regulatory affairs to uphold quality standards. This role often involves participating in daily operations meetings, addressing quality concerns, and coordinating root cause analyses for deviations or non-conformances. Effective communication and teamwork are essential, as you may be called upon to provide training, implement corrective actions, and support process improvements across departments. This collaborative environment helps ensure that all products meet both internal and external quality requirements.

What are the key skills and qualifications needed to thrive as a QA Operations Specialist, and why are they important?

To thrive as a QA Operations Specialist, you need a solid understanding of quality assurance processes, regulatory compliance, and analytical skills, often supported by a degree in life sciences or engineering. Familiarity with quality management systems (QMS), relevant industry standards (such as GMP or ISO), and tools like LIMS or TrackWise is typically required. Strong attention to detail, problem-solving abilities, and effective communication are the soft skills that set top performers apart. These skills are vital to ensure product quality, maintain regulatory compliance, and support continuous improvement in operational processes.

What is the difference between Qa Operations Specialist vs Quality Assurance Analyst?

AspectQa Operations SpecialistQuality Assurance Analyst
CertificationsISO, Six Sigma, QA certificationsISO, Six Sigma, QA certifications
Work EnvironmentManufacturing, software, or service industriesSoftware, manufacturing, or healthcare sectors
Employer UsageQuality departments, operations teamsQuality teams, product development
Primary FocusOverseeing QA processes, operations, and complianceTesting, identifying defects, and improving quality

Both roles involve quality assurance and often require similar certifications. However, Qa Operations Specialists focus more on managing QA processes and ensuring operational compliance, while Quality Assurance Analysts primarily conduct testing and defect analysis. The roles are complementary within quality management teams across various industries.

How much does a QA Operations Specialist make in the US?

A QA Operations Specialist in the US typically earns between $60,000 and $90,000 annually, depending on experience, location, and industry. Entry-level positions may start around $50,000, while experienced professionals with certifications can earn over $100,000. Salary also varies based on the complexity of testing tools and processes used.

Is QA an entry-level job?

Quality Assurance (QA) Operations Specialist roles can be entry-level or require some experience, depending on the company and specific responsibilities. Entry-level QA positions typically require basic knowledge of testing processes, attention to detail, and familiarity with testing tools or software. Advanced roles may demand prior experience, certifications, or technical skills in automation or scripting.

What cities are hiring for Qa Operations Specialist jobs?

Cities with the most Qa Operations Specialist job openings:

What states have the most Qa Operations Specialist jobs?

States with the most job openings for Qa Operations Specialist jobs include:

What are popular job titles related to Qa Operations Specialist jobs?

For Qa Operations Specialist jobs, the most frequently searched job titles are:

Infographic showing various Qa Operations Specialist job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 84% Full Time, 11% Part Time, 1% Temporary, 2% Contract, and 1% Nights. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $71,279 per year, or $34.3 per hour.

QA Operations Specialist I - Floor Support - C shift (Sunday-Wednesday 330pm-2am)

Bedford, NH • On-site

Full-time

Posted 10 days ago


PCI Pharma Services rating

6.3

Company rating: 6.3 out of 10

Based on 43 frontline employees who took The Breakroom Quiz


Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The QA Operations Specialist I - Floor Support is responsible for providing QA support of Manufacturing and Visual Inspection activities for clinical and commercial drug product in a GMP facility. The work scope includes on-the-floor Quality oversight of manufacturing activities including observing formulation and aseptic processes, performing AQL visual inspection of finished drug product vials, GMP documentation and Batch Record review, line clear and product changeover activities, disposition of incoming raw materials, review and approval of facility work orders, and other various QA functions as needed. Real time continuous monitoring of manufacturing related systems and processes to ensure compliance with applicable regulatory and industry standards, needed quality improvements, and safety/efficacy for phase appropriate GMP manufacture of drug products.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The QA Operations Specialist I - Floor Support is responsible for providing QA support of Manufacturing and Visual Inspection activities for clinical and commercial drug product in a GMP facility. The work scope includes on-the-floor Quality oversight of manufacturing activities including observing formulation and aseptic processes, performing AQL visual inspection of finished drug product vials, GMP documentation and Batch Record review, line clear and product changeover activities, disposition of incoming raw materials, review and approval of facility work orders, and other various QA functions as needed. Real time continuous monitoring of manufacturing related systems and processes to ensure compliance with applicable regulatory and industry standards, needed quality improvements, and safety/efficacy for phase appropriate GMP manufacture of drug products.
Essential Duties and Responsibilities:
  • Perform QA on-the-floor activities supporting client projects, including room release, auditing
  • critical processes, reviewing GMP documentation in real time.
  • Perform periodic walkthroughs of manufacturing and support areas to ensure adherence to
  • policies and procedures.
  • Batch record review for adherence to internal procedures and Good Documentation Practices
  • Support the evaluation and disposition of intermediates, finish bulk drug substance and drug
  • product.
  • Review, approval and disposition of incoming materials such as consumables, excipients, and
  • Active Pharmaceutical Ingredient.
  • QA review and approval of new and revised GMP documents such as SOP's and raw material
  • specifications.
  • Act as first responder for on the floor quality issues in a timely manner, documentation of all
  • events/investigations and required immediate corrective actions.
  • Assist in nonconforming material investigations.
  • Review of Quality Control environmental and utility monitoring data and test results
  • Review and approval of work orders impacting manufacturing facilities and utilities
  • May participate in root cause analysis using methodologies, such as: fishbone, 5 whys, etc.
  • Advise and coach internal customers on proper documentation of tasks
  • Assist in the initiation of Quality Systems (deviations, CAPA, Nonconformances).
  • Perform Acceptable Quality Limit (AQL) visual inspection of final drug product
  • Support Visual Inspection, packaging, and labeling operations
  • Create, review, and approve final product labels
  • Perform inspection of final product retains
  • Participate in SOP revision as it pertains to process improvements.
  • Participate in site quality and process improvement initiatives. Represent QA on project teams
  • and represent QA perspective as necessary.
  • Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP
  • compliance, internal procedures, regulatory requirements and industry best practices

QUALIFICATIONS:
Required:
  • Bachelor's Degree in a relevant scientific field.
  • Minimum 2 years' experience in relevant GMP industry preferred.
  • Equivalent combination of experience and education may be considered.
  • Exposure to RCA, technical writing, and working with quality related investigations.
  • Exposure to lean operation excellence highly desirable
  • Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working
  • with international regulations such as ICH
  • Knowledge and ability to apply basic scientific principles to solve operational, as well as routine

quality tasks.
  • Knowledge and exposure to using Risk Management Tools (FMEA, HACCP, PHA, etc.) and

familiarity with ICH Q9 preferred.
  • Scientific, technical, and mechanical subject matter comprehension and aptitude
  • Able to articulate scientific and technical subject matter

Preferred:
  • ASQ certification is referred.
  • Strong organizational skills and attention to detail
  • Ability to make risk-based decisions and resolve issues with minimal guidance.
  • Demonstrated positive interpersonal skills and the ability to communicate well orally and in writing.
  • Proficiency in MS Office including Word, and Excel
  • Ability to work in a dynamic, fast-paced work environment.
  • Honesty, integrity, respect and courtesy with all colleagues
  • Able to work with some limited supervision, able to escalate issues as needed.
  • Is flexible and adaptable through operational and organizational change.

#LI-RS1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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