QA Analytical Specialist

BEPC Inc. - Business Excellence Professional Consulting; Philadelphia (Philadelphia County); On-site; USD 69,000 - 75,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Job summary

BEPC Inc. in Philadelphia, PA is seeking an experienced QA Analytical Specialist to support GMP quality assurance operations for pharmaceutical and biotechnology products.

You will review QC data, approve test records, and support investigations to ensure regulatory compliance and product disposition. The role emphasizes collaboration with QA, QC, and Manufacturing teams to resolve analytical issues and maintain audit readiness, with a focus on documentation accuracy and scientific justification

Qualifications

• 2–5 years of pharmaceutical or biotechnology experience.
• Experience in GMP-regulated environment.
• Knowledge of analytical laboratory testing and QC investigations.
• Strong technical writing and documentation skills.

Responsibilities

• Review and approve QC analytical testing records and OOS investigations.
• Ensure testing performed per approved methods, specs, and filings.
• Review and approve internal/external analytical and microbiological results for materials and products.
• Verify compliance with US, EU, and international GMP requirements.
• Provide QA technical expertise to resolve analytical testing issues.
• Support investigations involving deviations, OOS results, and CAPA activities.
• Review closure of deviations, change controls, CAPAs, and quality investigations.
• Review batch records for bulk substances, drug products, and packaged lots.
• Evaluate results against specifications to support release and disposition.
• Inspect and release production materials against specs.
• Review CoAs for accuracy and compliance.
• Prepare CoAs for clinical and commercial products.
• Evaluate testing trends and identify quality concerns.
• Author and approve SOPs and other quality documents.
• Collaborate to improve GMP compliance.

Skills

GMP knowledge

QA analysis

Documentation

Cross-functional collaboration

Problem solving

Education

BS/BA in Biology, Chemistry, Engineering or related

Tools

Analytical instrumentation knowledge

Job description

Employment Type: W2 Contract – 12 Months with Possibility for Extensions

Pay Rate: $50.00–$54.72/hour – Based on experience (Paid Weekly)

Interview Process: Initial 30-Minute Virtual Screening Followed by a 30-Minute Virtual Panel Interview

Note: This is a W2 only role — C2C and C2H will not be considered.

Role Overview

BEPC is seeking an experienced QA Analytical Specialist to support our client's pharmaceutical and biotechnology quality assurance operations in Philadelphia, PA.

This position focuses on GMP quality assurance, analytical testing review, QC investigations, batch record review, and product disposition to ensure drug substances and drug products meet established quality and regulatory requirements.

The ideal candidate has 2–5 years of pharmaceutical or biotechnology experience, a strong understanding of Good Manufacturing Practices (GMP), and hands‑on knowledge of analytical laboratory operations, quality systems, and regulatory compliance.

This opportunity is well suited for a quality professional who enjoys collaborating with Quality Assurance, Quality Control, and Manufacturing teams to investigate analytical issues, improve compliance, and support the release of clinical and commercial pharmaceutical products.

Key Responsibilities

• Review and approve Quality Control (QC) analytical testing records, including associated Out-of-Specification (OOS) investigations.
• Ensure drug substance and drug product analytical testing is performed according to approved methods, specifications, and regulatory filings.
• Review and approve internal and external analytical and microbiological testing results for:
• Raw materials and starting materials
• Buffer solutions
• Bulk drug substances
• Drug products intended for clinical or commercial distribution
• Verify compliance with applicable US, EU, and international GMP requirements.
• Provide QA technical expertise to resolve analytical testing issues and laboratory quality concerns.
• Support investigations involving laboratory deviations, OOS results, and manufacturing‑related analytical issues.
• Review and ensure timely closure of deviations, change controls, Corrective and Preventive Actions (CAPAs), and quality investigations before material or lot release.
• Review executed batch manufacturing records for bulk drug substances, drug products, and packaged lots.
• Evaluate analytical results against approved specifications to support material release, product disposition, and quality decisions.
• Inspect and release production materials against established material specifications.
• Review vendor Certificates of Analysis (CoAs) for accuracy, completeness, and specification compliance.
• Prepare Certificates of Analysis (CoAs) for clinical and commercial products.
• Evaluate laboratory testing trends and identify potential quality concerns or unusual analytical results.
• Author, revise, review, and approve Standard Operating Procedures (SOPs) and other controlled quality documents.
• Collaborate with QA, QC, Manufacturing, and functional management to identify opportunities for GMP compliance improvement.
• Participate in internal QC laboratory audits and external contract testing laboratory assessments.
• Support regulatory inspections, audit readiness, and quality system compliance activities.
• Maintain accurate documentation and ensure quality decisions are scientifically justified and properly recorded.

Required Qualifications

• Bachelor's degree (BS/BA) in Biology, Chemistry, Engineering, or a related scientific discipline.
• 2–5 years of experience in the pharmaceutical or biotechnology industry.
• Proven experience working in a Good Manufacturing Practices (GMP)-regulated environment.
• Knowledge of analytical laboratory testing, analytical development, and laboratory equipment.
• Experience reviewing or evaluating QC analytical testing results and laboratory documentation.
• Understanding of quality management systems, including:
• Out-of-Specification (OOS) investigations
• Deviations and laboratory investigations
• Change control
• Corrective and Preventive Actions (CAPA)
• Knowledge of GMP compliance requirements and pharmaceutical quality standards.
• General familiarity with USP, European Pharmacopoeia (EP), ICH, and FDA guidelines.
• Ability to evaluate analytical data against approved specifications and identify potential quality issues.
• Strong technical writing skills, particularly for investigation reports and quality documentation.
• Excellent analytical, problem-solving, and critical‑thinking abilities.
• Strong attention to detail and commitment to documentation accuracy.
• Excellent written and verbal communication skills.
• Ability to collaborate effectively with QA, QC, Manufacturing, and cross‑functional technical teams.
• Strong organizational skills and ability to manage multiple quality activities and deadlines.

Preferred Qualifications

• 1–2+ years of analytical experience in a laboratory operations environment.
• Experience reviewing drug substance and drug product analytical testing records.
• Hands‑on experience supporting OOS investigations, laboratory deviations, and CAPA activities.
• Experience with batch record review, material disposition, and pharmaceutical product release.
• Familiarity with analytical and microbiological testing for clinical or commercial pharmaceutical products.
• Experience preparing or reviewing Certificates of Analysis (CoAs).
• Knowledge of analytical trending, specification compliance, and laboratory investigation procedures.
• Experience supporting internal quality audits, contract testing laboratories, or regulatory inspections.
• Background in biopharmaceutical manufacturing, drug substance production, or drug product quality assurance.

About BEPC

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top‑tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.