New · posted Nov 12
AstraZeneca · Pharmaceuticals
Quality Assurance Specialist II
- Frederick, MD
- On-site
- Full-time
- Associate & Specialist
The role
The Quality Assurance Specialist II provides Quality Assurance oversight for manufacturing and operational activities within a biopharmaceutical or pharmaceutical environment. The role is responsible for batch record review and release support, area release activities, review of electronic systems and manufacturing records, assessment of quality events, and execution of routine compliance activities.
The position works closely with Manufacturing, Quality Control, Quality Systems, Validation, Engineering, and other cross-functional teams to ensure that activities are performed in accordance with approved procedures, applicable regulations, and company quality standards. The role also contributes to continuous improvement initiatives and may support additional quality projects as assigned.
Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building functions, we take time to recognize our achievements and celebrate our diversity. We are dedicated to creating a culture of inclusion and collaboration and are committed to continuous learning by offering ongoing skill building and training for our staff.
Fueled by our aspiration to deliver accelerated growth for our company and to make people’s lives better, there’s never been a more exciting time to join the team and shape the future of AstraZeneca Operations.
Join us at AstraZeneca as a Quality Assurance Specialist within the Quality Systems group at Frederick Manufacturing Center. This role is designed to assist in all areas of quality systems, guided by the quality leads on the team. If you're ready to pioneer a new 'Quality way', this is the opportunity for you!
Date Posted
11-Nov-2026
Closing Date
01-Dec-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
What you need
Required Education and Experience
- Bachelor’s degree
- Minimum of three years of experience in a biopharmaceutical or pharmaceutical environment.
- Minimum of one year of experience in Quality Assurance, Quality Control, Validation, or a related quality function.
- Experience reviewing paper-based and electronic manufacturing documentation in a regulated environment.
- Experience working with quality systems, manufacturing records, deviations, observations, and compliance processes.
- Familiarity with electronic manufacturing and quality systems, such as PAS-X, DeltaV, PCS/BMS, GQCLIMS, LAP MODA, and SAP, is preferred or required according to site needs.
Desired Educationnice to have
A bachelor’s degree in biology, engineering, or a related scientific or technical field is required.
Knowledge, Skills, and Competencies
The Quality Assurance Specialist II should have a working knowledge of applicable GxP requirements, approved procedures, batch documentation practices, manufacturing processes, and quality systems. The role requires strong attention to detail and the ability to identify documentation discrepancies, assess potential quality risks, and escalate issues appropriately.
The successful candidate should demonstrate sound quality judgment, effective problem-solving skills, and the ability to work independently while collaborating with cross-functional teams. Strong written and verbal communication skills, effective time management, and the ability to manage multiple priorities are also required.
The role requires the ability to review manufacturing and electronic records, interpret process and equipment information, support deviation assessments, and contribute constructively to Lean and other continuous improvement initiatives.
What you'll do
- Batch Review and Release: Perform batch review and release activities for paper-based batch records and electronic batch records (EBRs), ensuring documentation is complete, accurate, compliant with approved procedures, and assessed for potential product-quality impact.
- Area Release Activities: Perform or support area release activities, including product changeover, return-to-service assessments, and execution of the Quality Assurance hold process.
- Area Audits: Conduct area audits on a quarterly basis and document findings in accordance with applicable procedures.
- Lot Genealogy Reports: Prepare and review lot genealogy reports to support product traceability and compliance.
- Quality Systems Support: Provide backup support to the Quality Systems function, as needed.
- Deviation Assessment: Assess quality events to determine whether deviation initiation is required in accordance with the applicable DAI process.
- Floor Observations: Review, document, and close floor observations within established procedures and timelines.
- Autoclave Review: Review autoclave run cycles to verify compliance with approved procedures and assess potential impact on product quality.
- Electronic Logbook Review: Review electronic manufacturing records, including PAS-X and DeltaV electronic logbooks.
- PCS/BMS Alarm Review: Review PCS/BMS alarms and evaluate relevant information for potential impact on product quality, equipment performance, manufacturing operations, or regulatory compliance.
- Quality and Manufacturing Systems: Use and support activities associated with applicable site systems and platforms, including GQCLIMS View/Labeler, LAP MODA View, and SAP Labeler, in accordance with assigned access privileges and established procedures.
- Continuous Improvement: Participate in continuous improvement projects, including Lean initiatives, to improve quality processes, compliance, operational efficiency, and right-first-time performance.
- Additional Responsibilities: Support other quality-related projects and responsibilities as assigned based on business and site needs.
Pay and benefits
$79,890 – $119,835 a year
Employer provided401(k) plan
Paid vacation and holidays
Paid leaves
Medical, prescription drug, dental and vision coverage
Short-term incentive bonus
Equity-based long-term incentive program
Where you'll work
Frederick, MDOn-siteOpen in Maps (opens in a new tab)
More jobs in Frederick, MDEqual opportunity, accessibility and legal noticesAstraZeneca's statements, word for word
The annual base pay for this position ranges from $79,890 to $119,835. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors terms of the applicable plans.
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 16% above the US median for Quality Operations & Batch Release roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US19 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $79,890 | — | $119,835 |
| All US (middle half) | $79,250 | $86,000 | $96,750 |
This role: AstraZeneca's own published range. Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 108 open Quality Operations & Batch Release roles on Regulatory Jobs, with the titles they carry most. Not AstraZeneca's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs13
- GMP and compliance9
- Quality systems and risk8
- Collaboration and leadership5
- Data and digital systems4
- Investigations and CAPA3
- Validation and qualification2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
Company hiring pulse
AstraZeneca on Regulatory Jobs
- 44
- Open roles
- 44
- Distinct roles
- 9
- Locations
By discipline
- Clinical18 41%
- Quality14 32%
- Regulatory12 27%
By level
- Director26 59%
- Associate & Specialist14 32%
- Senior & Principal2 5%
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Quality Assurance Specialist II at AstraZeneca
Applications close December 2. $80K–$120K a year, employer provided.