Qa Document Control Associate Job at Proclinical (Rockville)

QA Associate

Proclinical is recruiting a driven QA Associate to contribute to a highly regula...

Location

United States , Angleton

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences, Quality Management, or a related field
Experience in quality assurance, particularly in GxP sterile manufacturing operations
Strong technical understanding of manufacturing quality and regulatory requirements
Ability to work collaboratively in a team environment and communicate effectively with diverse groups
Willingness to work with radioactive materials while adhering to strict safety protocols
Proficiency in writing and reviewing SOPs and specifications
Inclusive mindset with a commitment to fostering a diverse and respectful workplace
Strong problem-solving skills, adaptability, and a results-oriented approach
Commitment to ethical behavior, continuous learning, and professional development

Job Responsibility

Adhere to GMP policies and ensure compliance with quality standards
Prepare, review, and maintain quality documents within the QMS (MasterControl), including document control and lifecycle management
Support training management by maintaining accurate training matrices and records
Assist with internal and external audits, supplier quality activities, and CMO oversight, including document reviews, audits, and quality agreements
Facilitate timely and compliant final product dispositions for manufactured products
Write, implement, and approve deviations, investigations, CAPAs, change controls, and complaint reports, ensuring timely closure
Ensure compliance with aseptic techniques and sterile manufacturing regulations
Manage supplier/vendor assurance activities and quality agreements
Lead FDA-regulatory interactions for site activities and products, supporting successful submissions and inspections
Collaborate with manufacturing, supply chain, and cross-functional teams to support batch review, release activities, and continuous QMS improvement

Sr Associate QA I

Sr Associate QA I at Amgen in Holly Springs, North Carolina. This is an on-site ...

Location

United States , Holly Springs

Salary:

82081.95 - 111052.05 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years Quality Assurance, manufacturing and/or other regulated environment work experience OR Associate's + 2 years Quality Assurance, manufacturing and/or other regulated environment work experience OR Bachelor's + 6 months Quality Assurance, manufacturing and/or other regulated environment work experience OR Master's

Job Responsibility

Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems
Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls
Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations
Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements
Oversee and provide guidance during on-the-floor analytical testing
Ensure that changes that could potentially impact product quality are assessed according to procedures
Ensure that deviations from established procedures are investigated and documented per procedures
Alert senior management of quality, compliance, supply and safety risks
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Sr. QA Associate I

The Sr. QA Associate I is a Quality Subject Matter Expert whom ensures manufactu...

Location

United States , San Diego

Salary:

36.54 - 41.11 USD / Hour

PCI Pharma Services

Expiration Date

Until further notice

Requirements

High school diploma or equivalent required
Bachelor’s degree preferred in a Life Sciences discipline or equivalent relevant experience required
Minimum of four to six (4-6) years of experience in documentation, QA, Manufacturing, technical quality, validation, or equivalent
Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices and data integrity
Knowledge of Fill Finish and Biologics production environments preferred
Familiarity working with electronic batch records
Detail oriented and strong interpersonal and verbal communication skills

Job Responsibility

Identify, investigate, resolve, and prevent compliance/deviance issues by real-time review of batch records and walk-through of the manufacturing areas
Independently reviews and approves production batch records and associated data for product release and determines if records are within range of cGMP regulations and good documentation practices
Independently performs quality operations within multiple manufacturing departments
Participates in multiple process improvement projects
Develop, revise, review and approve controlled documents including standard operating procedures (SOPs), Master Batch Records, analytical methods, protocols and tech transfer forms
Reviews and approves executed technical documentation in support of the manufacturing and testing of Drug Substance and Drug Product. Represents QA for high profile clients
Provides quality oversight of quality reports including deviations, corrective and preventive actions (CAPAs) and risk management plan (RMP)
Provides quality support to clients by attending meetings as needed, addressing quality issues that arise, and advising clients on compliant solutions
Supports the Facility/Equipment/Process Change Control System including developing recommendations for change tasks, managing timelines, and performing follow-ups to evaluate the effectiveness of changes
Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems

What we offer

eligibility for an annual performance bonus
paid time off
health insurance coverage (including dental and vision)
a flexible spending account
a 401(k) plan

Fulltime

Qa Associate

We're supporting a UK manufacturer of cannabis‑based medicines that has recently...

Location

United Kingdom

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

A relevant scientific or technical degree (or equivalent experience)
Experience in a quality focused position within a GMP production environment
Experience of GMP QMS
Comfortable working in a dynamic, change‑driven setting
Knowledge of GACP would be advantageous but training and support will be provided
to be considered for this position you will need to pass an enhanced DBS Check

Job Responsibility

Own core elements of the GMP QMS-write, update and review SOPs/records
ensure Good Documentation Practice
track SOP review cycles and training
and maintain complete, compliant records
Manage quality events-identify and raise deviations, lead root cause analysis, define and implement CAPAs, oversee change control and complete post‑implementation reviews, track metrics and report into the business
Drive inspection readiness-plan and run self‑inspections, conduct independent audits and risk assessments, and keep current with relevant regulatory requirements
Supplier & customer oversight-support approvals and liaise with external supplier QA where needed
Controlled drugs compliance-assist with Home Office licensing requirements as needed
Broader quality support-help maintain the GACP QMS alongside GMP activities

Fulltime

New

Quality Associate-I, QA Assurance

You will be responsible for maintaining Quality and Compliance by ensuring produ...

Location

Canada , Alliston

Salary:

72080.00 - 108120.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

University Degree, Bachelor of Science - Microbiology, Chemistry, Biological Sciences, Engineering / ASQ certification, other Quality Certification preferred or Combined Equivalent in Work Experience
Minimum 3 Years of experience required
Manufacturing and quality background
Previous experience in a GMP environment
Knowledge of cGMP, ISO, and Regulatory standards
Detail oriented with the ability to work under pressure
Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization
Ability to build strong relationships and partner with internal and external stakeholders
Strong ability to balance multiple priorities
Strong analytical and problem-solving skills with critical thinking abilities

Job Responsibility

Provide front line day to day support on product quality issues to ensure GMP, regulatory and procedural compliance to maintain high standards of quality
Support on assigned shift, with requirement to support plant overtime and planned shutdowns when applicable
Provide technical support on review/approval of department related procedural changes product quality issues, reinspection, new product introduction and Protocols
Partner with Quality and Production personnel to ensure mitigating actions are identified and implemented
Support timely follow-up on quality exceptions and their preventative/corrective actions
Support initiation/investigation and approvals of non-conformance events in the Trackwise system
Support release process by performing final release of products to distribution
Support Quality IT Systems
Ensure control of defective WIP materials
Ensure shop floor presence by performing process walkabouts and supporting operations to remediate issues

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Associate Principal QA Specialist

Provide QA review and oversight for various studies and activities. Support a cu...

Location

United Kingdom , Slough

Salary:

32.76 GBP / Hour

SRG

Expiration Date

Until further notice

Requirements

Education/Degree: Field of Study Scientific
Work Experience: Quality (QA or QC) Level- Advanced - 5-10 years
QA Manufacturing experience
TrackWise records experience (Deviations, Change controls, CAPA's, investigations)
OOS investigations

Job Responsibility

Provide QA review and oversight for various studies and activities
Support a culture of quality and continuous improvement within QC and Development Services
Support Operations to ensure ongoing compliance with GMP
Manage and support GMP issues through QMS processes, site governance and senior QA leadership
Act as a GMP Subject Matter Expert (SME) by implementing, managing and enforcing quality processes on site
Support senior QA leadership in driving continuous improvement and ensuring processes are 'fit for purpose'
Ensure compliance with GMP requirements within Development Services
Maintain compliance with Regulatory Authority expectations, Global Quality Standards and customer requirements
Provide shoulder-to-shoulder review, approval and support for deviations, CAPAs, change controls, investigations and OOS records
Review QA activities for MSAT studies, pilot studies, and Development Services

Fulltime

QA Validation, Senior Associate

Proclinical is seeking a Senior Associate, Quality Assurance Validation to provi...

Location

United States , Boston

Salary:

90.00 - 97.00 USD / Hour

Proclinical

Expiration Date

Until further notice

Requirements

A degree in Science, Logistics, or a related field is preferred
Strong knowledge of GxP regulations and ability to apply them to validation and operational activities
Hands-on experience in areas such as Quality Assurance, Quality Control, Manufacturing, Technical Support, Facilities Engineering, or Computerized Systems/Automation
Proficiency in managing change controls, deviations, and CAPA processes
Excellent cross-functional collaboration skills to drive compliant and practical outcomes
Highly organized and capable of managing multiple priorities in a team-oriented environment
Effective verbal communication skills to convey quality expectations clearly
Exceptional technical writing skills for validation and quality documentation
Adaptability and flexibility in a fast-paced, evolving environment
Continuous improvement mindset with a focus on innovation and process enhancement

Job Responsibility

Oversee the validation lifecycle, ensuring documentation accuracy, completeness, and compliance with regulations and internal procedures
Collaborate with teams across Validation Engineering, IT, Manufacturing, and other departments to develop and maintain risk-based validation strategies
Ensure validation activities align with regulatory expectations, including FDA, ICH, NIST, GAMP 5, and PIC-S guidelines
Provide quality input, review, and approval for change controls, deviations, CAPAs, and risk assessments to mitigate risks to product quality and data integrity
Promote inspection readiness through proactive issue identification and collaboration across GxP functions
Embed data integrity principles into all validation activities, systems, and documentation
Represent Quality Assurance Validation on project teams, offering strategic guidance and quality oversight
Utilize data-driven and risk-based methodologies to support effective validation outcomes
Demonstrate leadership behaviors that align with core values and foster a culture of quality and compliance

New

R&D Quality Laboratory Oversight (Associate Director)

Be a key quality leader ensuring high-quality, compliant analytical testing acro...

Location

Japan , Kanagawa

Salary:

Not provided

BioLife Plasma Services

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or related field
MS/PhD preferred
7+ years' experience in GxP laboratory quality oversight (GMP/GLP, analytical testing, inspections)
Strong knowledge of analytical methods and lab operations for small molecules and biologics
Proven skills in data integrity, deviation/CAPA management, and quality risk management
Clear communicator and collaborator, effective in a global matrix environment with competing priorities

Job Responsibility

Provide quality oversight for GxP and non-GxP labs across the R&D pipeline
Review and approve critical GMP/GLP documentation (methods, validations, deviations, CAPAs)
Ensure robust ALCOA+ data integrity controls in lab systems, processes, and records
Lead or support lab-related investigations, audits, and inspections with clear, timely CAPA
Collaborate with Pharmaceutical Sciences, Regulatory, Manufacturing, and QA to align on quality expectations

What we offer

Allowances: Commutation, Housing, Overtime Work
Salary Increase: Annually, Bonus Payment: Twice a year
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave
Flexible Work Styles: Flextime, Telework
Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Fulltime

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Qa Document Control Associate

Job Description

Job Responsibility

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