QC Associate (Raw Materials) Job at Amaris Consulting

New

Supervisor, QA Raw Materials

The Supervisor, QA Raw Materials is responsible for leading a team of QA Raw Mat...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in relevant scientific discipline with a minimum of 5+ years’ experience in related GMP industry working in Quality Assurance or Quality Control groups which support receipt, inspection, or release of materials
Equivalent combination of education and experience considered
Knowledge of USP and EP pharmacopoeias, and pharmaceutical raw material compendial testing
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as EU, ICH
Ability to apply basic scientific principles to solve operational and quality tasks
Experience with RCA, technical writing, and working with quality related investigations

Job Responsibility

Perform review of external documentation and internal GMP documentation associated with incoming raw materials, components, chemicals, excipients, and Active Pharmaceutical Ingredients (API)
Provide Quality Assurance oversight to Materials Management and Quality Control, ensuring that site SOP’s and raw material specifications are adhered to
Responsible for the review and analysis of test results
ability to interpret and comprehend scientific information and data related to QC Micro and QC Analytical testing
Initiation, review, and disposition or closure of raw material quality systems
Assist in the identification, isolation, and containment of potentially nonconforming materials
Assist in the identification and management of expired material
perform scrapping of materials with Materials Management
Assist Materials Management and Project Management with finished product shipments
Provide input, review, and approval of new and revised raw material specifications

Fulltime

New

Supervisor, Quality Assurance Internal Operations

Responsible for leading QA Associates, who provide QA support in the manufacturi...

Location

United States , Madison

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

BS degree in a scientific discipline
Minimum 5+ year’s relevant GMP experience
Knowledge of FDA/ISO regulatory requirements as well as industry trends
Computer knowledge, including Microsoft Office, Windows
Excellent interpersonal skills, must be able to lead and make decisions
College Level Mathematical Skills

Job Responsibility

Provide QA support for cGMP manufacturing operations
Coordinate with cross-functional teams to continually improve procedures with respect to area line clearances, labeling, packaging and material release
Support QA scheduling activities by monitoring the production, and visual inspection schedules and project management deliverables, and reviewing factors that may impact schedules
Oversee Quality System Events (QSEs) by verifying a Quality reviewer has been assigned to the QSE and monitor that the QSEs are being completed on time
Lead Associates in providing QA on the floor oversight of manufacturing
Oversee and assist employees with product / material labeling and disposition functions, routine manufacturing area line clearances, AQL Sampling and Inspection of Final Package Lots
Supervise the employees in the Quality Assurance Department
Ensure all training is performed by employees, including aseptic gowning, facility flow and visual inspection
Maintain Quality Metrics for the company
Review of master and executed raw material records. Release raw materials, as necessary

Fulltime

Associate Director, QC Manufacturing Support

We are seeking an Associate Director, QC Manufacturing Support to provide GMP ra...

Location

United States

Salary:

160000.00 - 180000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BS or advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, etc.)
10+ years of biotech industry experience in QC operations or analytical support roles
At least 6 years demonstrated experience supporting a GMP raw materials testing program
Understanding of analytical techniques relevant to monoclonal antibody testing
Experience in relationship management with external analytical test sites
Ability to effectively prioritize and manage multiple projects
Understanding of quality systems, cGMP regulations, and industry standards applicable to biopharmaceutical manufacturing and testing
Excellent communication skills
able to collaborate effectively across multidisciplinary teams
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

Job Responsibility

Author internal raw materials testing specifications, specifically for non-compendial raw materials
Assess test methods being used by CDMOs for non-compendial raw materials to ensure they meet industry expectations for method verification and/or validation
Perform change control activities to ensure internal raw material specifications are updated and communicated to impacted test sites
Review and assess impact of vendor change notifications related to GMP raw materials
partner with internal and external stakeholders to development plans for material changes with major impact
Provide general analytical support to DS, DP, and MSAT teams in conjunction with QC Analytical Sciences on coordination and execution of in-process analytical testing
may include review of manufacturing-related sampling/testing plans, supporting materials and process-related risk assessments, (e.g., extractables/leachables, nitrosamines, etc.), sample shipment coordination, and analytical data review and management
Interface with internal and external stakeholders to support manufacturing campaigns at CDMOs, including supporting requests for information, document review, and audits/regulatory inspections as required
Support deviations, OOS/OOT/OOE investigations, and CAPAs related to GMP raw materials and in-process testing

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Materials Handler I

The Materials Handler I assists in the day-to-day activities relating to invento...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Minimum 1-2 years’ related experience
Valid driver’s license
Willing to learn and adhere to cGMP requirements and safety policies and practices
Basic math and computer skills
ability to use Microsoft Suite
Good written and oral communication skills
Ability to follow instructions and established procedures
Ability to prioritize, to make good decisions and multi-task
Self-motivator, reliable, follows instructions and can perform duties with minimal guidance
Willing to put the team first

Job Responsibility

Assists in day-to-day activities relating to inventory control functions supporting pharmaceutical fill/finish operations
Assists with all aspects of logistics such as receiving, shipping, data entry, inventory control, labeling and maintaining all associated cGMP documentation
Creates and updates log sheets and inventory cards
Performs shipping activities and all inventory movement functions including updating databases, labeling and maintaining all associated cGMP documentation
Loads and/or unloads material between dock and truck with hand truck
Moves materials between statuses and locations within the plants
Processes delivered materials according to procedure placing an added immediacy on temperature sensitive receipts
Delivers received shipments accordingly
Prepares work-in-process (WIP) and lot specific kits supporting Manufacturing
Processes manufacturing and shipping supplies as outlined in procedures

Fulltime

Material Handler

The Materials Handler I/II/III assists in the day-to-day activities relating to ...

Location

United States , Madison

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Minimum of 1 year’s experience
Must possess a valid driver’s license
High School or Equivalency Basic math and computer skills
ability to use Microsoft Suite
Good written and oral communication skills
Ability to follow instructions and established procedures
Ability to prioritize, to ensure the key actions are followed through
Strong commitment to excellence and quality with a positive working attitude
Knowledge of ERP software is most helpful
APICS coursework or certification helpful, but not required

Job Responsibility

Assists in the day-to-day activities relating to inventory control functions supporting pharmaceutical fill/finish operations
Assist with all aspects of logistics such as receiving, shipping, data entry, inventory control, labeling and maintaining all associated cGMP documentation
Creating and updating log sheets and inventory cards
Shipping activities
All inventory movement functions including updating databases, labeling and maintaining all associated cGMP documentation
Loads and/or unloads material between dock and truck with hand truck where applicable
Moves materials between statuses and locations within the plants
Processes delivered materials according to procedure placing an added immediacy on temperature sensitive receipts
Delivers received shipments accordingly
Prepares work-in-process (WIP) and lot specific kits supporting Manufacturing

Fulltime

Associate I, Lab QA

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Detail Oriented
Continuous Learner
Courageous
Collaborative
Critical Thinker
Influential

Job Responsibility

To review the Raw material, packing material and finished product specification and to update department Head whenever required
To carryout investigation in case of out of specification (OOS) and deviation and take the corrective and preventive action (CAPA)
To ensure the calibration of all the analysis instruments is accurate
To sign off electronically the final document of sample set generated through Empower and all other softwares where (E-signature is applicable) for all the analysis in QC, stability & microbiology
To ensure the preparation of working standards as per the guidelines and pharmacopoeias
To ensure the review of calculation of the respective test protocol and daily release status
To ensure the testing of Raw material and packing material and analysis of in-process and finished product sample and it’s release according to standard operating procedure and specification
To ensure recording and documentation of all the data related to the testing on-line on daily basis and ensure the tractability of the same
To ensure preparation of the reagent and volumetric solutions
To support team members in preparation of SOPs

What we offer

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

Associate I, Lab QA

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Detail Oriented
Continuous Learner
Courageous
Collaborative
Critical Thinker
Influential

Job Responsibility

To review the Raw material, packing material and finished product specification and to update department Head whenever required
To carryout investigation in case of out of specification (OOS) and deviation and take the corrective and preventive action (CAPA)
To ensure the calibration of all the analysis instruments is accurate
To sign off electronically the final document of sample set generated through Empower and all other softwares where (E-signature is applicable) for all the analysis in QC, stability & microbiology
To ensure the preparation of working standards as per the guidelines and pharmacopoeias
To ensure the review of calculation of the respective test protocol and daily release status
To ensure the testing of Raw material and packing material and analysis of in-process and finished product sample and it’s release according to standard operating procedure and specification
To ensure recording and documentation of all the data related to the testing on-line on daily basis and ensure the tractability of the same
To ensure preparation of the reagent and volumetric solutions
To support team members in preparation of SOPs

What we offer

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

Sr. QC Associate I

10x Genomics is looking for a Sr. QC Associate I to join our Quality Control tea...

Location

United States , Pleasanton

Salary:

37.64 - 50.91 USD / Hour

10x Genomics

Expiration Date

Until further notice

Requirements

B.S. in Analytical Chemistry, Biochemistry, or a related field
5+ years of laboratory experience specifically in a QC environment
Strong hands-on experience with NGS and tissue-based assays (including immunofluorescence and flow cytometry)
Proficiency in PCR, qPCR, spectrophotometry, spectrofluorometry, and HPLC
Experience collaborating with R&D and QA on risk-based QC strategy assessment including assay robustness, assay cost, and alignment of QC checkpoints to the manufacturing process
A solid understanding of New Product Introduction (NPI) and manufacturing processes
Ability to manage and track diversified QC assays and projects in a rapidly evolving environment
Strong critical thinking, logical problem-solving skills, and the ability to communicate effectively with stakeholders

Job Responsibility

Execute QC Testing: Perform quality control operations according to defined procedures to ensure the integrity and quality of raw materials, intermediates, and finished goods
Data Analysis & Disposition: Complete QC testing in a timely manner and disposition materials based on established acceptance criteria
Product Development and Sustaining Support: Serve as the primary QC point of contact to oversee project completion, providing expert guidance on assay setup and assisting in the introduction and optimization of new products and processes
Assay Cross-Training: Cross-train on various inspections, including first article inspection, metrology, microscopy, analytical assays, and NGS
Documentation: Maintain quality control batch records and ensure Good Documentation Practices (GDP) under ISO requirements. Accurately track QC test data, calibration records, and inventory. Draft Work Instructions in collaboration with the Manufacturing Systems & Engineering team
Quality Compliance: Initiate non-conformance, deviation reports, engineering change orders (ECO) and follow up on necessary action items. Ensure that lab operations and workflow execution are compliant with ISO requirements
Problem Solving: Effectively identify and communicate complications arising from QC testing with minimal supervision. Work closely with scientists to establish and maintain technical solutions. Drive completion of investigations and minimize disruptions to QC operations

What we offer

Equity grants
Comprehensive health and retirement benefit programs
Annual bonus program or sales incentive program
Generous time off
Competitive and comprehensive health benefits package
Family friendly policies like parental leave

Fulltime

QC Associate (Raw Materials)

Amaris Consulting

Location:
Singapore

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 13, 2026

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Job Description:

Job Responsibility:

Requirements:

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