Senior Specialist Quality Control Jobs

Perform electronic archival of Category 1 and Category 2 packets and upload to server or document management system

Working knowledge of GMP, Quality Systems, and regulatory requirements (21 CRF Part 11/210/211/600/610), practices/principles

Master's Degree and 2+ years' experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations OR

Bachelor's Degree and 4+ years' experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations OR

High School Degree and 8+ years' experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations

Knowledge of relevant ICH and FDA guidance documents

Reports directly to Quality Control Lead/Manager

Completes Data Entry of all requests

Knowledge of grammar and punctuation

Entry level job duties include but not limited to

Entering data into database software and checking to ensure the accuracy of the data that has been inputted.

Resolving discrepancies in information and obtaining further information for incomplete documents.

At least 2 year industry experience (non academia) in QC

Experience in use of Empower, LIMS, CIMS and/or LMES (SmartLab) or other electronic laboratory notebook, templating preferred.

Bachelors Degree in Science or Engineering

Ability to problem solve and troubleshoot lab testing technologies.

Position Title – Quality Control Specialist- IS

Number of Openings – 1

Background in Medical Device industry is highly desired.Pharmaceutical experience only would be acceptable.

Technical Writing (author SOPs & Work Instructions)

Medical Device (pharmaceutical is fine)

This person will assume a hands-on role and report into the IT Business Partner.

This Candidate must have a background in the following:

2 years of experience with data quality management and regulatory requirements, Real Estate Appraisal, or related experience required.

Generate reports that provide information to the appraisers for inspection purposes, data entry and management as needed

Communicates effectively in verbal and written form with administrative staff, appraisal staff, supervisor and managers

Perform county wide core competencies

Establishes and maintains effective working relationships with supervisor, other employees, governmental agencies professionals and the public

Required – High School / GED

Required Knowledge, Skills and Abilities: knowledge of complex scientific/office procedures and techniques relating to position.

Excellent computer skills, including Microsoft Office software such as Word and Excel. Experience with technical writing and LIMS a plus.

CAMRIS International, LLC, offers competitive salaries and comprehensive benefits. Please submit your resume online at

BA/BS degree in Science (preferably chemistry, biochemistry, biology, microbiology, or engineering) and two years’ experience in a regulated laboratory environment.

Skills in using various types of analytical techniques and laboratory equipment.

Knowledge of aseptic technique, cGMP, cGLP or FDA regulations a plus.

Working knowledge of document management and lifecycle.

Advanced knowledge of Quality Management Systems (Deviation, CAPA, and/or Change Control)

Develop and implement procedures for effective data management.

Work with QC management to continually develop data management strategies.

Performs document management tasks for forms, procedures, and work instructions.

Performs document management tasks for writing reports, procedures, and work instructions.

Previous experience in Quality Control, supporting cannabis, pharmaceutical, manufacturing, or other regulated industry.

Exposure to and working knowledge of manual and computer-generated batch records and record keeping complying with state regulations.

Knowledge of Good Manufacturing Practices (GMP) standard operating procedures, checklists, and protocols.

Partnering with Packaging and Distribution teams to receive, seal, and audit all finished goods; including whole flower and pre-roll products

Overseeing the product receptacle sealing process; confirms all seals meet compliance and tamper-resistant standards

Ensuring all product and batch labels are compliant, accurate, and placed to standard

Experience using Laboratory Information Management System (LIMS) and Electronic Laboratory Notebooks (ELN) to document and report results

Report OOT/OOS results and other deviations to area management.

Knowledge and experience in microbiology methods and/or aseptic techniques and sample collection.

Participate in executing method validations and/or classified areas qualifications.

Knowledge of various laboratory equipment including Microbial ID systems, Chemical Analysis, pH meter, and balance. etc.

Demonstrate good communication skills, both verbal and written, at all levels and across various functions.

Minimum of 3 year experience hospital registration experience.

Ability to type with accuracy at a rate of 35 wpm with 98% accuracy.

Pleasant and professional appearance and attitude.

Support monthly QC reporting requirements as needed.

Act as backup for ProFlow requirements as needed.

Support statistical requirements and create charts for internal customers.

Supply charts of top 10 Mobile products to QC Manager for monthly reviews.

Minimum 3 years’ experience in laboratory and ISO environment preferred

Experience with information systems, preferably SAP and Synergi

Excellent interpersonal, verbal and written communication skills with strong technical writing experience.

Other related job duties as assigned.

Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 5 years’ experience in GMP environment.

Extensive knowledge of GLP and GDocP principles.

Capable of delivering to assigned work schedule with attention to detail and accuracy.

Support department risk assessments and participates in audit walk-throughs.

Experience using excel for analysis, and knowledge of PowerPoint, dashboard and Salesforce skills is helpful

Identifying and implementing opportunities to enhance a customer’s experience after they return from tour

Using story-telling as a means to help bring the customer experience to life

2+ years of prior customer-facing experience

2+ years of prior analytical experience

Experience managing delicate and complex situations and conversations

Responsible for ensuring all UL and FM compliance requirements are continually adhered to.

Bachelor’s degree in engineering or related field or equivalent job experience is desired.

Previous experience in a Quality Control or Quality Assurance role in a manufacturing environment, preferably plastics processing.

Trains production team on quality control measures to improve product excellence.

Create common business-specific quality measurements and track improvement against these metrics.

Plan and coordinate the work activities for inspecting products in a lab environment.

Minimum of 3 year experience hospital registration experience.

Ability to type with accuracy at a rate of 35 wpm with 98% accuracy.

Pleasant and professional appearance and attitude.

Experience working within regulations and compliance requirements

Manages reported quality issues and supports audits, assessments, and inspections

Bachelor’s degree in life sciences, business, or healthcare + 5 years of relevant Medical Affairs experience (e.g., Standards Alignment, Medical Operations)

Experience as a member in cross-functional, global initiatives in a complex matrix

Strong decision-making, problem-solving, and analytical skills, with ability to innovate with practical solutions for complex issues

Participates in several of the following core GMSA global initiatives and assumes varying degrees of project leadership

Sampling raw materials and manage sample send outs

3 + years’ experience in a QC laboratory GMP environment

HPLC / Chemistry and Microbiology QC experience

Understanding of FDA, EMA and ICH quality requirements

Perform in-process product testing and review of in-process, external lab data, release under cGMP.

Review and release QC test data.

Hands-on experience with the management of Change Controls, Deviations and CAPA is required.

Excellent oral and written communication skills with strong technical writing experience.

Knowledge of phase appropriate quality system and product lifecycle requirements.

Evaluate Supplier Change Notifications(SCN) and manage change controls related to SCNs to ensure closure in a timely manner.

In-depth knowledge of Good Manufacturing Practices (cGMP).

Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders.

3+ years of relevant experience in Pharmaceutical or Biotechnology industry is required.

Experience in cGMP procedures is strongly preferred.

Experience in at least two areas of the followings is required: cell culture, cell-based assays, immunoassays, and flow cytometry.

Experience with cell therapy QC methods is highly desired.

Excellent communication and interpersonal skills.

Support in-house QC testing: The QC Specialist may assist in-house quality control testing as needed.

Prepare RCM evaluation reports/audit findings and KPIs, and submit them to management and other interested stakeholders.

Problem Solving and analytical skills

Superior communication skills both verbally and written

Assesses situations to determine corrective action plans or actions needed for resolution in conjunction and with guidance from Supervisor or Manager

Interacts with employees professionally and raises concerns to the appropriate managerial level or Human Resources staff as needed

Demonstrated superior knowledge of departmental processes and procedures