Artech LLCLexington (MA), 15 mi from Framingham
Bioanalytical Data Reviewer/ Quality Control
HYBRID ROLE
Lexington, MA.
Pay Rate Range is $25.34-$32.97 Per hour.
MUST HAVES:
Experience being responsible for quality control of all scientific data generated within the Nonclinical Pharmacology...
US Tech Solutions, Inc.Lexington (MA), 15 mi from Framingham
Must Haves:
Experience being responsible for quality control of all scientific data generated within the Nonclinical Pharmacology group
Familiarity with Bioanalytical sample and data analysis
Attention to detail and experience with raw data QC...
GTT, LLCNorwood (MA), 16 mi from Framingham
Quality Control Raw Materials Associate
Contract Duration 6+ months
Pay rate up to $0.69/hr - $38.54/hr
The Role:
Reporting to the Associate Director of Quality Control, our client is seeking a Quality Control Raw Materials Associate II based...
Booz Allen HamiltonLexington
Cloud Application Migration Project Manager. As an Application Migration Program Manager, you know how to take advantage of cloud. Experience with project management tools, including Jira, Trello, or Asana. Knowledge of project management methodologies, including Agile, Waterfall, and DevOps.
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NCH Healthcare SystemBoston
The coordinator supports the functions of Quality & Patient Safety with clinicians, providers, and IT staff to improve EMR documentation to support quality data reports, mandatory quality reporting and performance metrics. The RN Safety & Quality Coordinator for Women & Child Health is a professiona...
NCH Healthcare SystemBoston
The RN Safety & Quality Coordinator Emergency Services & Sepsis is a professionally trained RN responsible for leading the efforts to advance patient safety culture and performance improvement throughout the Emergency Services and Sepsis management throughout the organization.
Certification in Healt...
NCH Healthcare SystemBoston
The RN Safety & Quality Coordinator Emergency Services & Sepsis is a professionally trained RN responsible for leading the efforts to advance patient safety culture and performance improvement throughout the Emergency Services and Sepsis management throughout the organization.
Certification in Healt...
Randstad Life Sciences USNorwood (MA), 16 mi from Framingham
Title: Quality Control Bioassay Associate I
Location: Norwood, MA
Pay: $25-32/hr
Contract: 6+ months
Multiple Shifts Available
Job Summary
The Bioassay QC Analyst 1 will be responsible for GMP release testing of products produced at the GMP...
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Associate Director, Plant Quality Assurance
Framingham | careers-replimune.icims.com |
Overview:
The Associate Director, Plant Quality Assurance (PQA) is responsible for the development, implementation and maintenance of Quality Assurance systems and activities at Replimune, with a focus on GMP production. Ensures all relevant quality and regulatory requirements are met for product manufacture and testing.
Ensures site compliance with quality system regulations issued by FDA, MHRA and other applicable regulatory bodies where Replimune clinical or commercial products are in use. Responsible for the evaluation and assurance that the validation of the aseptic qualification (media fill) program is maintained.
Develops and manages the QA staff performing batch review, aseptic process monitoring and other compliance functions.
This position is based in our Framingham location and typically has a 5-day on-site expectation.
Responsibilities:
Key Responsibilities:
• Oversees Plant Quality Assurance functions ensuring the inspection ready status of the aseptic qualification (media fill) program.
• Ensures that GXP systems are inspection ready and manages inspection readiness activities.
• Oversees and provides direction for the Plant Quality Assurance staff and ensures QA release, compliance and documentation functions are performed effectively.
• Interface with internal customers in Research, Product Development, Quality Control and Manufacturing/Operations.
• Oversees or facilitates Replimune's PQA interactions with external vendors such as contract manufacturing organizations, and other service providers to ensure compliance with Replimune requirements and GXP quality standards.
• Provide support to Chemistry & Manufacturing Controls (CMC) regulatory activities, to facilitate regulatory approval of the Company's products.
• Interface with Manufacturing and Quality Control to ensure on time batch review and disposition of Replimune clinical and commercial products.
Other Responsibilities:
• Ensures PQA staff is appropriately trained on an ongoing basis and maintain complete training records.
• Sets objectives for and appraises PQA staff
• Support Replimune Compliance activities to maintain an inspection ready status
• Drafts, reviews, provides oversight to content, and approves controlled documents which may include but is not limited to product specifications, standard operating procedures, validation documents, technical reports, quality policies, etc.
• Provide input in the establishment and implementation of validation philosophies and strategies to ensure a cGMP compliant program.
• Maintain up to date compliance knowledge and advise Replimune senior management accordingly.
• Other duties as required
Qualifications:
Educational requirements:
• BS or B.S. degree in an appropriate scientific field. M.S., Ph.D. or other post graduate degree is encouraged.
Experience and Skill Requirements:
• 10-15 years' experience in relevant Quality Systems, technology and management in a regulated biotechnology or pharmaceutical industry environment.
• Proven leadership in managing and motivating administrative and technical staff with strong awareness of the interface among Quality Assurance, Quality Control, manufacturing operations, and pre-clinical development.
• Appropriate GXP training.
• Knowledge of FDA and MHRA guidelines regarding GMPs.
• Excellent verbal and written communication skills.
• Good organizational skills.
• Computer literacy (including MS Word and Excel).
Location:
• This position is based in our Framinghamlocation and typically has a 5-day on-site expectation.
The Associate Director, Plant Quality Assurance (PQA) is responsible for the development, implementation and maintenance of Quality Assurance systems and activities at Replimune, with a focus on GMP production. Ensures all relevant quality and regulatory requirements are met for product manufacture and testing.
Ensures site compliance with quality system regulations issued by FDA, MHRA and other applicable regulatory bodies where Replimune clinical or commercial products are in use. Responsible for the evaluation and assurance that the validation of the aseptic qualification (media fill) program is maintained.
Develops and manages the QA staff performing batch review, aseptic process monitoring and other compliance functions.
This position is based in our Framingham location and typically has a 5-day on-site expectation.
Responsibilities:
Key Responsibilities:
• Oversees Plant Quality Assurance functions ensuring the inspection ready status of the aseptic qualification (media fill) program.
• Ensures that GXP systems are inspection ready and manages inspection readiness activities.
• Oversees and provides direction for the Plant Quality Assurance staff and ensures QA release, compliance and documentation functions are performed effectively.
• Interface with internal customers in Research, Product Development, Quality Control and Manufacturing/Operations.
• Oversees or facilitates Replimune's PQA interactions with external vendors such as contract manufacturing organizations, and other service providers to ensure compliance with Replimune requirements and GXP quality standards.
• Provide support to Chemistry & Manufacturing Controls (CMC) regulatory activities, to facilitate regulatory approval of the Company's products.
• Interface with Manufacturing and Quality Control to ensure on time batch review and disposition of Replimune clinical and commercial products.
Other Responsibilities:
• Ensures PQA staff is appropriately trained on an ongoing basis and maintain complete training records.
• Sets objectives for and appraises PQA staff
• Support Replimune Compliance activities to maintain an inspection ready status
• Drafts, reviews, provides oversight to content, and approves controlled documents which may include but is not limited to product specifications, standard operating procedures, validation documents, technical reports, quality policies, etc.
• Provide input in the establishment and implementation of validation philosophies and strategies to ensure a cGMP compliant program.
• Maintain up to date compliance knowledge and advise Replimune senior management accordingly.
• Other duties as required
Qualifications:
Educational requirements:
• BS or B.S. degree in an appropriate scientific field. M.S., Ph.D. or other post graduate degree is encouraged.
Experience and Skill Requirements:
• 10-15 years' experience in relevant Quality Systems, technology and management in a regulated biotechnology or pharmaceutical industry environment.
• Proven leadership in managing and motivating administrative and technical staff with strong awareness of the interface among Quality Assurance, Quality Control, manufacturing operations, and pre-clinical development.
• Appropriate GXP training.
• Knowledge of FDA and MHRA guidelines regarding GMPs.
• Excellent verbal and written communication skills.
• Good organizational skills.
• Computer literacy (including MS Word and Excel).
Location:
• This position is based in our Framinghamlocation and typically has a 5-day on-site expectation.
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