Senior Quality Control Associate Jobs

Excellent interpersonal skills with ability to work effectively with individuals at all levels (i.e. Management, CM, Development, etc.)

Apply software testing skills to ensure high quality software in multiple domains

Experience in developing comprehensive and accurate test designs and plans

Experience designing and executing black, white and gray box test conditions

Strong verbal and written communication skills

Experience with a comprehensive set of testing types, including unit, regression, integration, freestyle, and acceptance testing

Time management skills to optimize the analysis process and perform multiple tasks at the same time.

General knowledge of Federal and State regulatory requirements in a GxP environment.

Lead analytical method development/optimization/qualification and stability study projects.

Operate, calibrate, troubleshoot and maintain analytical equipment. Assist in laboratory equipment qualifications (IQ, OQ, PQ, and MQ).

Familiar with current GLP/cGMP, FDA, ICH, USP, and ISO regulations and guidelines, laboratory documentation, safety, and environmental requirements.

Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.

Must possess strong organization skills

Perform documented methods required for finished product quality testing

Review manufacturing documentation for process deviations

Communicate analyzed results in detailed written reports.

Maintain archive of control sample inventory required for product testing

Maintain accurate and detailed records

Sound knowledge of cGMPs or equivalent Regulations. A minimum of 1 year of experience working in a GMP environment is required.

Independently manage competing priorities with limited instruction.

Coach colleagues and help them develop expertise/skills in related functions.

Perform other duties as requested by managers to support QC activities.

BS Degree with at least 5 years of work experience in similar roles.

Hands-on industrial laboratory experience with analytical techniques such as HPLC, UPLC.

Determine if incoming orders match criteria as stated on the purchase order, and if a problem exists, inform the QC Manager.

Perform miscellaneous duties as assigned by the QC Manager.

Inspect incoming orders to ensure quality of merchandise meets established standards.

Attach scanned labels to corresponding cases.

Resolve any discrepancies that might exist between quantities received and quantity stated on the vendor ASN.

Ability to talk and hear

Responsible for detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.

Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.

Laboratory experience, including Cell Culture, Bioassay, Aseptic Technique, and ELISA

Knowledge in LIMS, QTS, SAP, eQMS, MODA, etc.

Excellent effective written and verbal communication and interpersonal skills

Perform testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.

Requires proficient knowledge of job area typically obtained through advanced education combined with experience. May have practical knowledge of project management.

Perform product inspections in accordance with the applicable specifications/ drawing requirements and review supporting assembly instructions.

Experience in micro circuits and/or circuit card assemblies

Experience evaluating complex electronic hardware, under magnification, to IPC-J-STD-001 and/or NASASTD-8739 is required.

Certified, or the ability to obtain certification to the above referenced workmanship standards

Experience with engineering drawing review and interpretation

Conducts review of logbooks and may perform reviews as assigned by management

Excellent interpersonal, verbal and written communication skills with strong technical writing experience required and ability to work in a team environment.

Other related job duties as assigned.

Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 2 years’ experience in GMP environment.

Direct experience in cell handling and potency testing.

Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties.

Experience with the technical transfer and qualification/validation of analytical assays.

$34.00 (entry-level qualifications) to $39.00 (highly experienced)

Lead the testing of assigned lot release and stability samples to meet expected turnaround time requirements.

Participate in method qualification, validation and transfer activities.

Support instrument installation and operational qualification activities (IOQ).

Ensure a compliant work space by adhering to and enforcing GxP requirements.

Maintain compliance with applicable ICH, GLP, GMP and safety regulations. Notify management of unexpected results, procedural deviations and equipment problems.

Record data per GxP requirements. Provide peer review of documentation as needed.

At least 1 year of experience in GMP pharmaceutical environment.

Senior Manager Quality Control, Biologics CMC

Perform sampling, testing and release of raw materials and in process testing.

Perform testing as per current approved test method and maintain accurate laboratory records and adhere to cGMP/GDP expectations.

Support detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.

Experience and knowledge of GMP, following standard test methods.

Author standard operating procedures, assay qualifications and other GMP documents as necessary

Perform assay qualifications for in-process, drug substance, buffers, etc. and author reports

Demonstrated understanding of USP, EP and FDA microbiological testing requirements

Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.

Maintain compliance with applicable ICH, GMP and safety regulations. Notify management of unexpected results, procedural deviations and equipment problems.

Perform Raw material sampling, testing, record data as per GxP requirements.

Hands on experience with Change controls, Deviations and CAPA is required.

Bachelor’s degree in scientific discipline (Chemistry, Biochemistry, Biology) + At least 5 years of experience in GMP pharmaceutical environment.

Master’s degree in scientific discipline (Chemistry, Biochemistry, Biology) + At least 2 years of experience in GMP pharmaceutical environment.

Lead and support GMP compliances and general QMS activities.