CrawlJobs Logo

Sr. QA Specialist - Ops

pci.com Logo

PCI Pharma Services

Location Icon

Location:
United States , Bedford

Category Icon
Category:
Quality Control

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

The Sr. QA Specialist – Team Lead will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. The role supports and provides quality oversight client facing QA Operations including Batch Record Review, Lot Disposition, Investigations, CAPAs and Quality System review. The Sr. QA Specialist – Team Lead will also manage oversight of the QA staff and be able to provide feedback and development to enhance team capability. In this role, the opportunity exists to shape and transform GxP programs by providing QA expertise and guidance to the manufacture of both clinical and commercial products.

Job Responsibility:

  • Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
  • Review and approve master batch records for the timely initiation of GxP manufacturing activities
  • Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
  • Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
  • Provide direction for complex investigations and CAPAs
  • Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
  • Review, develop, and improve quality system procedures, specifications, and test methods
  • Review and approve CAPAs to prevent recurrence of deviations
  • Review and approve Change Control documentation
  • Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participate in the management review process
  • Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner.
  • Monitor, identify and propose quality process and system improvements. Lead improvement projects and communicate status to management
  • Serve as QA Team Lead to provide quality oversight of manufacturing day-to-day operations, including oversight of QA Team workload prioritization and deliverables.
  • Serve as QA lead to cross functional project teams such as tech transfer, process validation, and process improvement
  • Coordinate change control review meetings
  • Monitor status of change controls and facilitate the approval process
  • Perform risk assessments to comply with internal procedures and external guidelines
  • Provide training on department specific procedures and systems
  • Interface with clients to address any documentation and compliance concerns
  • Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable
  • Ensures site readiness for regulatory inspections

Requirements:

  • 7-9 years of pharmaceutical or biotech industry
  • 4+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
  • Bachelor’s Degree in a relevant scientific discipline preferred
  • Experience performing RCA, technical writing, and working with quality related investigations
  • Knowledge of laboratory and production equipment and IQ/OQ/PQ
  • Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
  • Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
  • Ability to Travel 10%

Nice to have:

  • ASQ certification preferred
  • Exceptional organizational skills and attention to detail
  • Ability to make risk based decisions and resolve issues with minimal guidance
  • Excellent interpersonal skills and the ability to communicate well orally and in writing
  • Proficiency in MS Office including Word, Excel, Access and Visio
  • Excellent verbal and written communication skills required
  • Ability to work in a dynamic, fast paced work environment
  • Honesty, integrity, respect and courtesy with all colleagues
  • Creative with the ability to work with minimal supervision and balanced with independent thinking
  • Resilient through operational and organizational change

Additional Information:

Job Posted:
January 02, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Icon
PCI Pharma Services - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Sr. QA Specialist - Ops

New

Chef de partie

We're looking for experienced chefs to join the team at The Bulls Head East Leak...
Location
Location
United Kingdom , East Leake
Salary
Salary:
12.21 - 13.50 GBP / Hour
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Passionate foodies who are committed to delivering high standards
  • Experienced chefs with prior kitchen experience
  • Skilled communicators who thrive in a team environment
  • Chilled Pubs enthusiasts who are excited to be part of our growing family
  • Flexible workers who are comfortable with evening and weekend shifts
Job Responsibility
Job Responsibility
  • Food Safety: Compliance is our number one priority
  • Culinary Skills: Show off your fresh food and cooking expertise
  • Teamwork: Work confidently in a large team to produce high-quality food in a fast-paced environment
  • Quality & Efficiency: Cook and prepare dishes to company specifications while managing ticket times
  • Ownership: Take charge of your area, managing orders and maintaining smooth kitchen operations
  • Versatility: Support different sections of the kitchen as needed
  • Cleanliness: Ensure safety, sanitation, and organisation at all times
What we offer
What we offer
  • Up to 70% discount across all Chilled Pubs
  • Paid day off on your birthday
  • Christmas & New Year’s Day off every year
  • 28 days paid holiday
  • Potential to earn more through shared tips (especially at busy sites!)
  • Access to Wage-Stream (get your salary early)
  • Career development opportunities – we love to promote from within
  • Monthly incentives, competitions, and yearly ‘Dennis Awards’ dinners
  • A sociable team where you’ll feel like family
  • Pension scheme (available after 3 months)
  • Fulltime
Read More
Arrow Right
New

Electrician

Our division in the charming small town of Noti, Oregon is seeking a qualified s...
Location
Location
United States , Noti
Salary
Salary:
41.36 - 45.52 USD / Hour
spi-ind.com Logo
Sierra Pacific Industries
Expiration Date
January 25, 2026
Flip Icon
Requirements
Requirements
  • 2 years’ recent verifiable related work history or equivalent education
  • Licensed through the state of Oregon to perform electrical work
  • Understanding of industrial electrical safety, MCCs, three-phase power, running conduit, lighting, electrical, and hydraulic systems required
  • Read and understand blueprints and circuit diagrams
Job Responsibility
Job Responsibility
  • Install, maintain, and repair electrical systems and equipment in manufacturing facility
  • Maintain all components required to control machinery, including switches, sensors, programmable logic controllers, variable frequency drives, and operate interface units
  • Recognize and effectively identify hazards and correct electrical defects
  • Perform preventative maintenance on all electrical systems and equipment
  • Inspect and maintain motors, switches, junction boxes, switch panels, circuit breakers, transformers, fuse panels, and lighting
  • Read and interpret blueprints, schematics, and electrical specifications to determine layout of industrial electrical installations
  • Install electrical conduit and pull wire
  • Maintain efficiency and safety of all plant electrical circuits, assembles, and equipment
  • Troubleshoot and install encoders, linear transducers, vision systems, and other advanced sensors
  • Identify and help implement process improvements to optimize performance and production
What we offer
What we offer
  • We train and promote from within
  • Excellent low-cost health benefits
  • Retirement plan with employer-paid contributions
  • Paid vacation and 10 holidays
  • Full Health Benefits Plan (including medical, dental, and vision) with low-cost premiums
  • 401(k) with Company Match
  • additional Retirement Contributions
  • company-paid Life Insurance
  • Fulltime
Read More
Arrow Right
New

Tax Manager

The Tax Manager will be responsible for state income tax provisions, returns, no...
Location
Location
United States , Englewood
Salary
Salary:
130000.00 - 145000.00 USD / Year
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree in Accounting
  • 8+ years of tax accounting experience
  • Strong knowledge and experience with state income tax
Job Responsibility
Job Responsibility
  • Review and prepare quarterly state income tax provisions, ensuring accurate documentation and communication of tax positions to auditors and senior management
  • Coordinate and oversee the preparation of state income tax returns in collaboration with external accounting firms, conducting thorough reviews of their work
  • Handle state tax notices by responding to inquiries and coordinating audit responses, including managing information document requests
  • Analyze and explain the company's state tax positions and their impact on tax returns and liabilities, including forecasting annual state tax obligations
  • Collaborate with subsidiaries and accounting teams to gather critical data, such as apportionment and depreciation, affecting state income tax filings
  • Manage and maintain the state tax calendar, including overseeing the preparation and submission of estimates and extensions
  • Supervise and interact with external tax advisors, including national and local accounting and law firms, to address tax-related matters
  • Conduct multistate tax planning and nexus analysis to optimize tax strategies for the organization
  • Advise management on new and proposed state tax legislation, judicial rulings, and administrative guidance, assessing their impact on the company and its ventures
What we offer
What we offer
  • bonus
  • medical, vision, dental, and life and disability insurance
  • 401(k) plan
  • Fulltime
Read More
Arrow Right
New

Learning Support Assistant

We are looking to appoint a Learning Support Assistant to provide effective supp...
Location
Location
United Kingdom , Church Stretton
Salary
Salary:
13.26 GBP / Hour
shropshire.gov.uk Logo
Shropshire Council
Expiration Date
January 09, 2026
Flip Icon
Requirements
Requirements
  • Keen interest in supporting young people to overcome barriers to success
  • Energetic and tenacious in their approach to systems that promote the good behaviour and academic success of students
  • Excellent communication skills and a willingness to work flexibly within our friendly SEND team
Job Responsibility
Job Responsibility
  • Provide effective support in our SEND department
  • Parttime
!
Read More
Arrow Right
New

Relationship Manager

At KFH we are looking for a Relationship Manager to join our Build to Rent Team....
Location
Location
United Kingdom , London
Salary
Salary:
Not provided
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • A proven track record in property management or a similar client-facing role
  • Experience managing contractors and resolving issues effectively
  • Strong communication skills – written, verbal, and over the phone
  • CRM system experience
  • A proactive, organised, and detail-oriented approach
  • The ability to build trust, work collaboratively, and stay resilient under pressure
Job Responsibility
Job Responsibility
  • Managing property visits and inspections
  • Coordinating safety checks and compliance documentation
  • Handling maintenance requests and contractor appointments
  • Resolving tenancy issues and deposit disputes
  • Overseeing insurance claims and legal obligations
  • Supporting team collaboration and service excellence
What we offer
What we offer
  • Additional earning potential and discounts
Read More
Arrow Right
New

Electrician

Currently, we are seeking a qualified Electrician to perform building and mainte...
Location
Location
United States , Lincoln
Salary
Salary:
41.89 - 43.78 USD / Hour
spi-ind.com Logo
Sierra Pacific Industries
Expiration Date
January 23, 2026
Flip Icon
Requirements
Requirements
  • 2 years' recent verifiable related work history or equivalent education
  • Understanding of industrial electrical safety, MCCs, three-phase power, running conduit, lighting, electrical, and hydraulic systems required
  • Read and understand blueprints and circuit diagrams
Job Responsibility
Job Responsibility
  • Install, maintain, and repair electrical systems and equipment in manufacturing facility
  • Maintain all components required to control machinery, including switches, sensors, programmable logic controllers, variable frequency drives, and operate interface units
  • Recognize and effectively identify hazards and correct electrical defects
  • Perform preventative maintenance on all electrical systems and equipment
  • Inspect and maintain motors, switches, junction boxes, switch panels, circuit breakers, transformers, fuse panels, and lighting
  • Read and interpret blueprints, schematics, and electrical specifications to determine layout of industrial electrical installations
  • Install electrical conduit and pull wire
  • Maintain efficiency and safety of all plant electrical circuits, assembles, and equipment
  • Troubleshoot and install encoders, linear transducers, vision systems, and other advanced sensors
  • Identify and help implement process improvements to optimize performance and production
What we offer
What we offer
  • We train and promote from within
  • Excellent low-cost health benefits
  • Retirement plan with employer-paid contributions
  • Paid vacation and 10 holidays
  • full Health Benefits Plan (including medical, dental, and vision) with low-cost premiums
  • a 401(k) with Company Match
  • additional Retirement Contributions
  • company-paid Life Insurance
  • Fulltime
Read More
Arrow Right
New

Food & Beverage Team Member

Join a fun and energetic team to help create amazing experiences for guests. The...
Location
Location
United Kingdom , Fareham
Salary
Salary:
Not provided
aztechotelbristol.co.uk Logo
Aztec Hotel & Spa
Expiration Date
February 15, 2026
Flip Icon
Requirements
Requirements
  • Friendly and extremely personable
  • Ability to deliver company standards in each interaction
  • Enjoy working in a busy environment
  • Great work ethic
  • Previous experience in a bar, café or restaurant is ideal but not essential
Job Responsibility
Job Responsibility
  • Greet guests with a warm and friendly smile
  • Take food and drink orders and serve guests with brilliant customer service
  • Assist with menu suggestions and recommendations
  • Prepare perfectly laid tables for each guest visit
  • Ensure high standards are delivered and maintained at all times
  • Provide warm hospitality to ensure guests want to return
What we offer
What we offer
  • Tips paid monthly
  • Stream - access up to 40% of wages as earned each week
  • 28 days annual leave (rising to 33 days after 5 years)
  • Free meal whilst on duty
  • Employee Assistance Programme
  • Enhanced maternity and paternity pay
  • Apprenticeships available
  • Discounted accommodation, food and drink in properties across the country
  • Free use of gym on site and discounted spa treatments
  • Free car parking (where applicable)
  • Parttime
Read More
Arrow Right
New

Managing Surveyor

Following an internal promotion, we’re recruiting a Managing Surveyor to our Lee...
Location
Location
United Kingdom , Leeds
Salary
Salary:
Not provided
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven experience in a similar commercial or Senior Quantity Surveying role ideally from within the repairs/maintenance sector
  • Some people management responsibilities/experience
  • A proven ability to minimise cost and maximise value, profit, and cash flow effectively, from within a maintenance contracting environment or similar/relatable industry focused on high volume invoicing based on low value costs
  • Strong people skills: you will enjoy supporting, directing and collaborating with your team to encourage and facilitate growth and development
  • Excellent IT and Microsoft Excel skills, with the ability to process high volumes of data analysis
  • Experience of working with direct labour and subcontract procurement
  • Experience of working on Schedule of Rates contracts, with the ability to price minor works from first principles
  • Strong commercial instincts and influencing skills
  • Experience in Repairs and with utilising SOR
  • A track record of managing subcontractors and dealing with dispute resolution
Job Responsibility
Job Responsibility
  • Developing and maintaining a high performing Surveying team to ensure delivery of responsive repairs contracts are at or above, agreed profit performance
  • Overseeing and managing financial and technical aspects of each contract, including procurement, invoicing, and payments to minimise costs, maximise value and cash flow, and meet profit and debtor day targets
  • Subcontractor management and the oversight of any disputes arising
  • Mentoring and training new surveyors and trainees
  • Supporting all commercial aspects within your unit and the wider response product, where applicable
  • Managing the contract accounting and ensuing prompt payment, control cost information
  • Preparing CVRs and valuations to closely monitor contract performance, striving for better solutions and outcomes and steering the commercial contract performance
  • Developing and maintaining positive and collaborative relationships with your direct reports, colleagues, customers/clients, subcontractors, and suppliers
  • Taking full accountability for the commercial function of the Responsive Repairs and Void (vacant properties) works for our reputable housing clients in and around Leeds
  • Working closely with colleagues in our Middlesbrough and Bolton offices, managing, developing, and nurturing a high-performing commercial team of Quantity Surveyors and Trainee Surveyors
What we offer
What we offer
  • Be part of the company profit share scheme (14% of base salary achieved last year)
  • Car allowance of £7,250 private mileage scheme benefit and fuel card
  • Enhanced employer pension contribution of up to 7% OR a savings scheme
  • Life, Medical and Permanent Health Insurance
  • 23 days annual leave, plus bank holidays, but you may want longer or less, so buy up to 5 days or sell up to 3 days per year
  • Access to the Lighthouse Construction Industry Charity to support your health and wellbeing, including free legal and financial advice
  • Enhanced maternity/ paternity pay
  • Annual pay reviews
  • Training and development opportunities
  • Trade discounts from our preferred suppliers for you and your friends and family
  • Fulltime
Read More
Arrow Right
Welcome to CrawlJobs.com –
Your Global Job Discovery Platform
At CrawlJobs.com, we simplify finding your next career opportunity by bringing job listings directly to you from all corners of the web. Using cutting-edge AI and web-crawling technologies, we gather and curate job offers from various sources across the globe, ensuring you have access to the most up-to-date job listings in one place.
Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Poland Jobs Ireland Jobs Germany Jobs
Company
Blog About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy